What is Adverse Event Reporting (AER)?

The process of Adverse Event Reporting (AER) involves the systematic recording and submission of information about adverse events that occur during the use of medical products (drugs, devices and vaccines) Such reports contribute significantly to the surveillance of product safety by regulatory agencies, allowing for prompt action when needed to ensure public health and safety.

Importance of Reporting in Medical Devices

Adverse events are any unexpected, harmful or untoward medical occurrence related to the use of the medical product in humans not necessarily caused by the product. Reporting of adverse events in medical devices is a critical part of post-market surveillance aimed at ensuring the continued safety and performance of medical devices after their use. This includes the identification, documentation and reporting of incidents in which the device may have caused or contributed to injury, death or malfunction. Adverse events can be reported by manufacturers, importers, distributors, healthcare providers and patients/consumers.

Reporting Requirements and Key Information

Reporting requirements for adverse events (AEs) vary according to jurisdiction, type of organisation and severity of the event. Serious incidents causing death, serious injury or deterioration of health; requiring medical or surgical intervention or causing permanent impairment should be reported. A recurring device malfunction which has the potential to cause serious harm should be reported. The regulatory authorities usually require information related to reporter, device, date of occurrence, description of the events, outcome and severity. If the reporter is a manufacturer, details related to corrective and preventive actions, recalls, field safety corrective actions, if any are also required. when a medical device adverse event report is submitted. The objective is to present a comprehensive and unambiguous image of the event, device, and patient outcome.

Global Regulatory Frameworks and Reporting Systems

Every nation has set up a different regulatory framework with distinct reporting procedures, specifications, and deadlines for tracking and handling incidents involving medical devices. Manufacturers, medical professionals, and regulatory affairs specialists working in a global market must comprehend these distinctions.

United States – FDA

The Food and Drug Administration (FDA) is in charge of regulating medical devices in the US. The Manufacturer and User Facility Device Experience (MAUDE) database and the MedWatch application are the main reporting platforms. Adverse events must be reported by manufacturers, importers, and device user facilities in accordance with the Medical Device Reporting (MDR) regulation (21 CFR Part 803). The eMDR system must be used to electronically submit reports. The FDA mandates that events requiring immediate corrective action be reported within five workdays, and that serious injuries or deaths be reported within thirty calendar days. The FDA can respond promptly to safety communications and recalls thanks to this strong system. The TPLC and MAUDE database searches are integrated in CAPTIS® platform of Celegence. It enables the medical writers to seamlessly conduct database searches and analysis of the search results to obtain quality outcomes.

European Union – EUDAMED

The Medical Device Regulation (EU) 2017/745, which requires the reporting of serious incidents and field safety corrective actions, governs medical devices in the European Union. EUDAMED (European Database on Medical Devices) is the EU’s central database for medical device vigilance. Incidents must be reported by importers, manufacturers, and authorized representatives; patients and healthcare providers may voluntarily report through the appropriate national authorities. The deadlines are strict: death or a major decline in health must be reported within two days, major public health threats must be reported right away, and other serious incidents must be reported within ten to fifteen days.

United Kingdom – MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) was the regulatory pathway that the United Kingdom established. Systems like the Manufacturer’s Online Reporting Environment (MORE) and the Yellow Card Scheme are still used in the UK to report adverse events. Within a certain amount of time—two days for public health threats, ten days for fatalities or serious injuries, and fifteen days for other reportable incidents—manufacturers and their UK Responsible Persons are required to report serious incidents.

Canada – Health Canada

Health Canada is in charge of medical device safety in Canada through the Medical Device Problem Report system and the Canada Vigilance Program. According to the law, distributors, importers, and manufacturers must report unfavorable incidents. Timelines for reporting incidents are set at 30 days for other incidents and 10 days for events that pose a serious risk. Reports may be submitted via specified forms or electronically.

Australia – TGA

The Incident Reporting and Investigation Scheme (IRIS) is run by the Therapeutic Goods Administration (TGA), Australia’s regulatory body. According to Australian laws, healthcare providers may choose to report adverse events voluntarily, but sponsors—including importers and manufacturers—must report them. According to severity, the reporting deadlines are tier-based: two days for major public health threats, ten days for major injuries or fatalities, and thirty days for less important incidents.

Japan – MHLW and PMDA

Medical device vigilance in Japan is a joint responsibility of the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Marketing authorization holders can report more easily thanks to the J-MEDWATCH system. If an adverse event is considered serious, it must be reported within 15 days; for less serious incidents, reporting must be done on a regular basis. The highly structured regulatory environment in Japan places a strong emphasis on traceability and documentation.

China – NMPA

Adverse event reporting in China is regulated by the National Medical Products Administration (NMPA) via a national electronic monitoring system. Manufacturers, holders of marketing authorizations, and healthcare facilities are required to report. For other kinds of incidents, regular safety updates are necessary, and serious adverse events must be reported within 15 days. In recent years, China’s regulatory framework has undergone significant modernization, bringing it closer to international norms.

India – CDSCO

The Materiovigilance Programme of India (MvPI) is run by the Central Drugs Standard Control Organization (CDSCO), India’s regulatory body, to keep an eye on adverse events linked to medical devices. While hospitals and medical professionals voluntarily participate through Adverse Drug Reaction Monitoring Centers (AMCs), manufacturers and importers are obligated to report incidents. India strives to conform to international reporting standards, despite the fact that timelines are not as clearly stated as in other nations.

Global Challenges in Adverse Event Reporting

A crucial but difficult part of international health systems is the reporting of adverse events for medical devices. A number of factors, including underreporting, inconsistent regulatory frameworks, divided responsibilities, technological constraints, and cultural considerations, contribute to the complexity. A diversified strategy is needed to address these issues, including coordinating global standards, making investments in digital infrastructure, encouraging a transparent and safe culture, and utilizing advanced analytics to improve signal detection.

The Role of Technology in Adverse Event Management

The application of advanced technologies, such as Artificial Intelligence (AI) and Machine Learning, is being investigated for their potential to augment signal identification and pattern recognition within extensive AE (Adverse Event) databases. Furthermore, the fusion of AE documentation with Electronic Health Records (EHRs) can automate data acquisition, alleviate the workload of clinicians, and enhance the precision of the data.

Toward Safer and More Reliable Medical Devices

In conclusion, medical device adverse event reporting is essential to patient safety and preserving the integrity of healthcare systems. It facilitates prompt regulatory actions and ongoing product development by gathering real-world data on device performance and related risks. Its efficacy is hampered by issues like underreporting, disjointed regulatory frameworks, and poor technological integration. In order to get past these obstacles, manufacturers, medical professionals, regulators, and patients must work together. Post-market surveillance will be strengthened and everyone will eventually have access to safer and more dependable medical devices thanks to the development of digital reporting systems, the standardization of international standards, and the promotion of an open culture.

Contact us today at info@celegence.com to learn how we can help your team with global adverse event reporting and strengthen your medical device compliance strategy.

Once a product is confirmed as a combination product, the next step is identifying its Primary Mode of Action (PMOA). This is defined as the single mode of action that provides the most important therapeutic effect of the product.

If the product’s intended therapeutic benefit is primarily achieved through a chemical or metabolic interaction, then it is typically drug-led. If the effect is driven by physical means, such as mechanical support or energy transmission, it is considered device-led.

The PMOA determines which FDA center will lead the regulatory review. For example:

• Drug-led products are generally reviewed by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
• Device-led products fall under the purview of the Center for Devices and Radiological Health (CDRH).

Understanding this distinction is crucial because it dictates the regulatory submission pathway, data requirements, and even post-approval compliance expectations.

Comparing Drug-Led and Device-Led Pathways

To illustrate the regulatory differences, the table below outlines key contrasts between the two classifications:

In cases where the PMOA is not obvious, the FDA may determine the lead center based on precedent or safety and effectiveness concerns. This is why early interaction with the FDA is strongly encouraged.

Gray Areas and Borderline Scenarios

Innovative therapies don’t always fit neatly into predefined categories. Consider, for example, a therapeutic powder that forms a gel upon hydration and controls the release of a drug physically, without any chemical reaction. While it may appear to be a simple formulation, the polymer mechanism may qualify as a device component. In such borderline cases, even the excipient could be classified as a regulated device.

Another emerging gray area involves digital health integrations. Take the example of an antipsychotic pill embedded with an ingestible sensor to track adherence. Although the drug provides the treatment, the device aspect introduces complexity in classification. FDA treated this as a drug-led combination product with additional review of the device software and hardware elements.

Sponsors dealing with similar situations should not assume a default classification. Instead, they should seek clarity from the FDA early, using the pathways discussed below.

Engaging the FDA: RFD and Pre-Submission Pathways

To avoid ambiguity and regulatory missteps, the FDA offers sponsors two main avenues for determining classification:

1. Request for Designation (RFD)
   The RFD is a formal process through which the sponsor asks the FDA’s Office of Combination Products (OCP) to determine whether the product is a combination product, and if so, which center will lead the review. The FDA is required to respond within 60 days, providing a binding decision.
2. Pre-Request for Designation (Pre-RFD)
   This is a less formal, non-binding method to engage FDA on classification questions. Sponsors can initiate Pre-RFD discussions to explore how the agency views their product, receive preliminary input, and prepare more confidently for the full RFD if needed.Engaging FDA through these channels early in development ensures that sponsors follow the correct regulatory path and gather the appropriate data from the start.

Developing a Regulatory Strategy

After classification is determined, sponsors must design a development strategy that aligns with the assigned pathway.

For drug-led products, this typically involves:

• Filing an Investigational New Drug (IND) application.
• Conducting clinical studies focused on safety and efficacy.
• Submitting a New Drug Application (NDA) or Biologics License Application (BLA).
• Demonstrating that any device component (e.g., injector, delivery system) is safe, functional, and appropriate for the intended user population.

For device-led products, development may involve:

• Submitting a Pre-Submission (Q-Sub) for FDA feedback.
• Filing an Investigational Device Exemption (IDE) if clinical studies are needed.
• Preparing a 510(k), De Novo, or Premarket Approval (PMA) submission.
• Including supporting drug data to ensure safety of the drug component, even if secondary.

Sponsors must also comply with hybrid quality systems, combining drug GMP (21 CFR Parts 210/211) and device QSR (21 CFR Part 820). The FDA has published 21 CFR Part 4 to provide guidance on integrating these systems for combination product development.

Recent Regulatory Updates (2023–2025)

In the past few years, FDA has introduced several new guidances that significantly impact combination product development:

• Combination Product User Fees (2024): Clarifies which user fees apply when submitting a single combined application for a combination product.
• Use-Related Risk Analysis (2024, Draft): Encourages risk assessments tied to user interaction—especially important for auto-injectors and at-home devices.
• Human Factors Engineering (2023): Offers a Q&A-style guide for incorporating usability studies in combination product submissions.
• Drug-Device Software (2023, Draft): Discusses regulatory expectations for mobile apps, sensors, and digital interfaces that form part of a combination product.
• Premarket Pathways for Combination Products (2022): Affirms that most combination products can follow a single submission path, and outlines principles for determining when more than one submission may be needed.

Each of these documents provides valuable insight into FDA expectations, helping sponsors avoid roadblocks and design programs that meet current regulatory standards.

Key Takeaways for Developers in 2025

Combination product development is a multidisciplinary challenge, requiring strategic foresight and active regulatory engagement. Here are four key takeaways for sponsors:

• Start with clear classification: Use 21 CFR 3.2(e) and, when in doubt, engage the FDA early via Pre-RFD or RFD.
• Build your development strategy based on PMOA: Whether your product is drug-led or device-led, understand how that affects submission type, testing, and timelines.
• Address both components: Ensure your development plan includes appropriate testing for both drug and device aspects—neither can be neglected.
• Stay current with FDA guidance: Regulatory expectations are evolving. Human factors, software integration, and use-risk analysis are now central considerations in many combination product reviews.

With a proactive and informed approach, sponsors can reduce regulatory uncertainty, improve submission quality, and bring combination therapies to patients faster.

Celegence offers comprehensive regulatory consulting services tailored for combination products, providing strategic guidance on classification, regulatory submissions, and compliance with both drug and device regulations. Their expert guidance helps streamline development processes, mitigate risks, and facilitate timely market entry for complex combination therapies.

Clinical Evaluation Reports (CERs) are often associated with EU MDR, but an increasing number of manufacturers are now integrating CERs into their FDA submissions, particularly for devices requiring robust clinical evidence. This approach allows manufacturers to present a clear, comprehensive clinical evidence package, ensuring alignment with FDA expectations and reducing review timelines.

CERs in the Context of FDA Submissions

Unlike the EU MDR, the FDA does not mandate a standalone CER as part of a 510(k) or PMA submission. However, substantiating safety and performance of a device through clinical data is a fundamental expectation of the FDA. Clinical evidence plays a pivotal role in FDA review, especially for:

• Novel devices without predicates
• De novo applications
• Devices with high-risk profile
• PMA supplements requiring new safety data

What to Watch For: Common Pitfalls

1. Inadequate Clinical Data
   An unsystematic literature review may result in inclusion of irrelevant or inadequately appraised clinical data, or poorly analyzed data. Additionally, relying on EU-based data without appropriate consideration of its relevance to the U.S. clinical context can further weaken the submission.
2. Lack of Understanding of Submission Types
   Submitting the wrong type of application may lead to significant delays or rejection. Failing to understand the specific requirements associated with the chosen submission type can lead to missing critical information.
3. Unsubstantiated Clinical Claims
   If the clinical data does not directly support the intended use or labelling of the device, it may lead to questions from the reviewer or delays. Each safety and performance claim should be clearly substantiated with traceable evidence.
4. Underutilization of Real-World Evidence (RWE)
   Adverse event trends, registry data, and post-market studies provide real-world evidence that can further enhance the risk-benefit assessments. Not leveraging this data is a missed opportunity to strengthen the submission.
5. Lack of integration across submission sections
   Lack of alignment between clinical, risk, and labeling sections can make it difficult for reviewers to interpret the submission. Maintaining consistency across all sections is essential.

Considerations for a CER aimed at FDA Review

Although CERs are not mandated by FDA, manufacturers should consider the following when drafting a CER to support regulatory submissions:

• Discussion of data relevance, especially for U.S. population
• Clear summary of the clinical evidence, including published literature, registry data, and clinical trials
• Analysis of risks, adverse events, and benefits in alignment with device labeling
• Refer to FDA-recognized standards and guidance, like 21 CFR 814 or the Clinical Evidence Premarket Submission guidance

Useful Tools & Resources

Developing CER content for FDA submissions can be time-consuming, particularly when teams are handling multiple submissions or working under tight timelines. The following tools and data sources can help streamline the process:

• FDA MAUDE Database – for adverse event data and comparator analysis
• ClinicalTrials.gov – to identify relevant ongoing and completed clinical trials
• PubMed and Embase – to identify relevant peer-reviewed clinical literature
• FDA Guidance Documents – to align the CER content with FDA expectations
• FDA CDRH Learn – to stay updated on submission requirements and review trends

These resources are most effective when used strategically, supported by internal alignment and medical writing expertise.

How Celegence Supports CER Preparation for FDA Submissions

Preparing a CER or clinical justification for FDA review isn’t just about data gathering. It’s about crafting a clear, well-structured narrative supported by robust evidence. This is where Celegence adds value.

We combine regulatory expertise with technology to deliver submission-ready CERs, literature reviews, and clinical summaries—on time and in line with FDA expectations.

What sets us apart?

• Clinical writers experienced in FDA and EU submissions
• AI-powered literature reviews and data extraction using CAPTIS®
• Integration of FDA databases and guidance documents into writing workflows
• Quick turnaround times for 510(k), PMA, and De novo pathways
• 99% first-time acceptance rate of clinical documents by regulatory reviewers

Whether you need a literature-based justification, a full CER-style report, or gap analysis of your existing documentation—we offer flexible solutions for every stage of development and submission.

Let’s Work Together

Need help aligning your clinical evidence with FDA expectations? Celegence delivers accurate, regulatory-ready CER support backed by proven expertise and AI tools. Contact our team today to get started.

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alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]EU MDR Clinical Evidence: Meeting the Mark for Regulatory Compliance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” 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The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) represents a significant shift in the regulatory landscape for medical devices in the European Union, and has led to stricter requirements for clinical evidence. The European Union Medical Device Regulation (EU MDR) requires manufacturers to provide clinical evidence to demonstrate the safety and performance of their medical devices. This evidence is crucial for obtaining and maintaining CE marking, which allows devices to be sold in the EU.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]What Is Clinical Evidence Under EU MDR?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

As per EUMDR clinical evidence can be defied as clinical evaluation as “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.” This evidence should be specific to the device of interest and should be able to demonstrate the safety and performance of the device.

The data can be from various sources like but not limited to:

• Data from clinical investigations: These can be performed by the manufacturer, mostly for high-risk devices to collect safety and performance data.
• Published Scientific literature: Article or publications in peer reviewed journals can also be used to provide clinical evidence for scientific devices.
• PMS data: These data reflect real world evidence for the device as they are collected once the device is launched in the market.
• AE databases/Registries: These databases provide specific data for the device related to the reported AE or other details also specifically in terms of registries

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When and Where Is Clinical Evidence Required

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Clinical evidence is required in both premarketing and post marketing phase of device lifecycle in EUMDR. In the premarket phase the manufacturer needs to collect data from clinical investigation and literature to assess the safety and performance of the device. In the post market phase real world clinical evidence can be collected to update the Clinical evaluation documents as necessary. All this data should be used in the CER and should be updated as necessary.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

What Standards or Thresholds Must Be Met?

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To be considered acceptable, clinical evidence must be:

• Device-Specific and Relevant: The data should be specific device and should be aligned to its intended purpose, target patient population, and risk profile. In terms of equivalence the equivalence should be clearly justified clinically, technically and biologically in the CER. Additionally, the data should be sufficient quantitively also.
• Scientifically Robust: Data must be of high-quality, credible, and considered from reliable sources such as clinical investigations, peer-reviewed literature, and structured literature reviews using recognized search methodologies.
• Continuously Updated: Clinical evidence is not static. The CER must be updated regularly, particularly when new risks emerge, performance data changes, or the device is modified. Also based on the device risk there is a review period after which the CER should be revised irrespective of any reasons mentioned before. Additionally, there should be ongoing surveillance for post marketing data for the devices.

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Who Verifies EU MDR Clinical Evidence?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]The verification of clinical evidence is primarily conducted by Notified Bodies. These are organizations designated by EU member states to assess the conformity of medical devices with the MDR requirements. The review can be of clinical evaluation or technical documentation, on site review or even PMS audits.

The bar for clinical evaluation has risen significantly, and these bodies are increasingly strict about the sufficiency, traceability, and quality of the data.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Common Pitfalls in Clinical Evidence Preparation

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

The most common problem currently is the lack of proper clinical evidence to support safety and performance of the device. Another major challenge which is being currently faced by manufacturers is the lack of proper clinical investigation planning. Failing to implement a robust PMS plan or specific PMCF plan also leads to lack of clinical data for the device. Finally, inconsistent documentation, the technical document for a device should align in term of all internal information like intended purpose, claims, warnings precautions etc.

[/fusion_text][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”23267|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Accelerate Clinical Evidence with CAPTIS®” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/05/Accelerate-Clinical-Evidence-with-CAPTIS®.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How Celegence Helps You Stay Ahead – Powered by CAPTIS^®

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

At Celegence, we understand the weight clinical evidence carried under EU MDR. That’s why our regulatory experts, clinical writers, and technologists work together to ease this burden for device manufacturers.

Our proprietary platform, CAPTIS^®, supports every step of the clinical evidence development process:

• • AI-Powered Systematic Literature Reviews – CAPTIS^® uses intelligent algorithms to extract relevant data quickly and accurately, reducing manual effort and review cycles.
  • Automated Data Consistency Checks – CAPTIS^® ensures clinical data across documents is aligned, flagging inconsistencies before they’re submitted.
  • Advanced Search & Data Retrieval – From real-time adverse event databases to journal articles, CAPTIS^® connects you to the most relevant sources in moments.
  • Audit-Ready Documentation – The platform generates clear, traceable reports that meet the expectations of Notified Bodies.
  • Collaboration Tools – Clinical, regulatory, and quality teams can work together within CAPTIS^® to maintain alignment across documentation.

Combined with our expert writing and consulting services, we deliver fully MDR-compliant CERs, PMCF plans, and literature reviews—all with quick turnaround time.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Partner With Celegence

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Clinical evidence under EU MDR doesn’t have to be a bottleneck. With the right partner—and the right tools—you can build submission-ready documentation that stands up to regulatory scrutiny.

Talk to our clinical evidence team today and reduce your compliance burden with confidence.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

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filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” min_height=”” link=””][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”23203|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”How Celegence Leverages CAPTIS to conduct Efficient Benefit-Risk Analysis for Medical Devices ” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” 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caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/04/Celegence-Leverages-CAPTIS-to-conduct-Efficient-Benefit-Risk-Analysis-for-Medical-Devices-1-1.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How Celegence Leverages CAPTIS^® to conduct Efficient Benefit-Risk Analysis for Medical Devices

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]In the fast-paced world of medical device regulatory affairs, conducting a thorough benefit-risk analysis is a time-consuming yet critical task. At Celegence, we understand these challenges firsthand. That’s why we utilize CAPTIS^® our powerful AI-driven platform that streamlines literature reviews, automates adverse event data retrieval, and simplifies report writing. By leveraging cutting-edge technology, our medical writers deliver faster, more accurate, and regulatory-compliant reports, giving our clients a distinct advantage.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Why Choose Celegence for Your Benefit-Risk Analysis?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Medical writers often struggle with:

1. Scattered Data Sources: Managing literature references, risk assessments, and extracted data across multiple systems is inefficient.
2. Manual Data Extraction: Identifying risks and adverse events from literature takes time and is prone to human error.
3. Cumbersome Adverse Event Searches: Searching the FDA’s MAUDE database is a manual, fragmented process.
4. Time-Intensive Report Writing: Ensuring consistency across risk data, literature findings, and device descriptions requires significant effort.

At Celegence, we overcome these challenges using CAPTIS^®, allowing us to deliver benefit-risk analysis reports with unmatched speed and precision.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How Celegence Uses CAPTIS® to Achieve Efficiency

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1. • Ensure Full Traceability: No more scattered information—every literature reference and review decision is stored in one place.
   • Identify & Tag Risks Seamlessly: Our writers tag risks and adverse events directly from literature sources, aligning them with risk files.
   • Leverage AI for Data Extraction: AI-powered prompts streamline data identification, allowing us to extract key risk-related information effortlessly.Literature Review Data – A Single Source of Truth: CAPTIS^® centralizes all literature references, review decisions, PDFs, and extracted data, enabling our medical writers to:
2. AI-Generated Summaries for Faster Analysis: CAPTIS^® enhances our workflow by automatically summarizing literature findings, ensuring:
   • Consistent and Comprehensive Reporting: AI-generated summaries align with regulatory requirements.
   • Accelerated Report Drafting: Instead of manually compiling literature data, our team focuses on strategic analysis, while CAPTIS^® handles the generation of literature tables and other data management tasks.
3. Automated MAUDE & TPLC Data Retrieval: Celegence uses CAPTIS^® to automate adverse event data retrieval from the FDA’s MAUDE and TPLC databases, offering:
   • Instant Access to Device Names with Reported Issues for the configured product codes.
   • Multi-Device and Manufacturer Selection for efficient searching.
   • Bypassing MAUDE’s 500-Result Constraint for full data retrieval.
   • One-Click Data Downloads for streamlined reporting.
   • Device vs Industry Totals, a functionality not available on the FDA website.
4. Faster, More Accurate Report Writing & Review: With CAPTIS^®, Celegence streamlines the entire report-writing process:
   • Integrated Source Document Linking: Product information, device descriptions, and risk data are included directly from the source files with automatic content links to the original content location.
   • Effortless Multi-Department Collaboration: Our report writing module allows seamless collaboration to include contributions from risk teams, medical affairs, R&D, PMS, and external experts.
   • Accelerated Review Process: Content links enable instant traceability, speeding up reviews and approvals.
   • AI-Powered Literature Summaries and Extractions: Our team uses AI prompts to align literature summarization with benefit-risk analysis requirements, improving accuracy and efficiency.

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Why Work With Celegence?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

At Celegence, we don’t just write reports—we optimize the entire drafting process using advanced AI-powered technology. Our team, equipped with CAPTIS^®, ensures that your reports are comprehensive, accurate, and delivered faster than traditional methods.

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Partner with Us for Best-in-Class Benefit-Risk Analysis

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Ready to experience the efficiency of AI-driven benefit-risk analysis? Partner with Celegence today and let our technology-enabled medical writers streamline your regulatory documentation. Contact us at info@celegence.com for a consultation and see how we can enhance your reporting process!

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Enhancing Systematic Literature Reviews for Adverse Events with AI

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The primary pillar of the EU MDR is patient safety. Irrespective of the risk classification or nature of device, all devices are expected to meet rigorous safety standards to ensure that they do not cause any harm to patients. One of the most effective ways of ensuring device safety is through adverse event reporting. One of the primary sources of identifying adverse events related to device use is literature. A systematic literature review is a methodical, structured process for gathering, screening, extracting data and synthesizing research on a specific topic. The goal is to uncover patterns, gaps, and trends in the available evidence.

Unlike traditional reviews or essays, an SLR follows a set process that includes defining research questions, selecting studies, and assessing their quality and relevance. Systematic literature reviews are essential for compiling data on the safety and performance of the medical device into its Clinical Evaluation Reports (CER) to meet regulatory requirements. These reviews provide a thorough and unbiased assessment of the safety and performance of medical devices by analyzing data from multiple sources.

The process involves several key steps:

• Literature Search: Identifying relevant studies from various databases such as PubMed, Embase, and Cochrane. Identification is facilitated by defining a research objective and defining appropriate keywords and search strings to pull the most appropriate results on the topic of interest.
• Screening: Filtering studies based on predefined inclusion and exclusion criteria.
• Data Extraction: Extracting relevant data, including study type, study subjects, demographics, interventions used, performance outcomes of interest and adverse events.
• Data Synthesis: Summarizing and synthesizing the extracted data to draw meaningful conclusions.

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Challenges in Conducting SLRs

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Conducting systematic literature reviews is a time-consuming and labor-intensive process. It requires an elevated level of accuracy and attention to detail to ensure that all relevant studies are included and correctly evaluated. The sheer volume of literature to be reviewed can be overwhelming for regulatory professionals leading to inefficiencies, delays, and compliance risks especially when traditional manual methods are applied. Improperly analyzed and presented, specifically presenting missing or partial data, can create a skewed understanding of the true safety risks associated with a device, leading to gaps in safety assessment. Manual data extraction, since subjective, is also often associated with inconsistent interpretation of adverse events, especially when it comes to complex medical terminology or subtle details.

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Leveraging Advanced Tools for SLRs

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At Celegence, we leverage advanced tools like CAPTIS^® to streamline the SLR process. CAPTIS^® is an AI-powered platform that automates many of the labor-intensive tasks involved in SLRs. Here’s how CAPTIS^® enhances the SLR process:

• Automated Literature Search and Screening: CAPTIS^® quickly searches and de-duplicates identified literature from a multitude of different databases. CAPTIS^® allows for automatic download and storage of articles where the full text is available freely online making the analysis easier with immediate access to data. With the use of specific keywords CAPTIS^® can also highlight potentially relevant or irrelevant articles. This significantly reduces the time and effort required for the different stages of the review process.
• Data Extraction and Summarization: CAPTIS^® automatically extracts relevant information from research articles, such as study type, study subjects, demographics, interventions used, and adverse events. This information is summarized within seconds, allowing medical writers to be more efficient and consistently meet deadlines. CAPTIS^® also facilitates identification and extraction of adverse events in a way that reduces or eliminates the subjectivity and inconsistencies when handling large data sets manually.
• Enhanced Collaboration: CAPTIS^® enables seamless collaboration and communication among team members. From literature search to screening and appraisal, team members can collaborate and leave feedback on the platform itself

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Case Study: AI-Powered SLRs at Celegence

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In a recent project, Celegence utilized CAPTIS^® to conduct an SLR for a medical device manufacturer. The AI-powered platform automated the literature search, facilitated faster screening, and automated the data extraction processes, reducing the time required for the review by an impressive 60%. The data extracted was also presented consistently despite being a large volume negating the need for additional time to be spent on standardizing the content prior to data analysis.

This allowed the regulatory team to focus on data synthesis and analysis, ensuring a thorough and accurate evaluation of adverse events.

[/fusion_text][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”23139|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Why Literature Reviews Should Be Done with CAPTIS®” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” 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animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/04/Why-Literature-Reviews-Should-Be-Done-with-CAPTIS®.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” 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Driving Safer, Smarter Reviews with AI-Powered Precision

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Systematic literature reviews are a critical component of regulatory compliance for medical devices. By leveraging advanced tools like CAPTIS^®, regulatory professionals can streamline the SLR process, improve efficiency, and ensure compliance with regulatory requirements. At Celegence, we are committed to providing innovative solutions that enhance the safety and performance of medical devices, ultimately improving patient outcomes.

See how our AI-powered solutions can transform your regulatory processes. Contact us at info@celegence.com to learn more.

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Clinical Evaluation Report Template and CAPTIS^®

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Clinical evaluation for medical devices is a systematic process that is used to assess the safety and performance of a medical device by analysing clinical and non-clinical data. This evaluation helps demonstrate compliance with the existing regulatory requirements. It also helps in demonstrating that the device is safe to use and performs when used as per the manufacturer’s instructions. The process of evaluation of a device clinically is continuous and continues till the device lifetime. To keep the data up to date periodic revision is done along with the revision of associated documents like Post marketing survey documents (PMSR, PMSP etc).

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Key Documents in the Clinical Evaluation Process

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For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

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For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Structure and Content of a Clinical Evaluation Report

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The document is created in a template compliant to EUMDR. Medical Device coordination Group (MDCG 2020-13) provides a Clinical Evaluation Assessment Report (CEAR) template which is useful while creating the document. Major sections for the CER include:

• Executive Summary
• Background/Introduction
• Device Description
• Data Held by Manufacturer and External Data
• Data Analysis Including Risk-Benefit Analysis
• Conclusions

The sections within a CER are deeply interconnected, each contributing to the overall assessment of a medical device’s compliance with EU MDR. From the device description and clinical data to benefit-risk analysis and post-market surveillance, the information in each section flows seamlessly, supporting the next. This interconnectedness ensures a cohesive narrative, where each section reinforces the others, ultimately leading to a well-supported conclusion that demonstrates the device’s safety, performance, and regulatory compliance.

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CAPTIS^®: Simplifying the Clinical Evaluation Report Process

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Celegence CAPTIS^® is designed to navigate this complexity of the CER sections. It is designed to cater to the needs of medical device manufacturers of all sizes, helping them achieve compliance with EU MDR and IVDR regulations more efficiently. It is a compliance software tool designed to streamline the creation of various regulatory documents for medical devices, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Summary of Safety and Clinical Performance (SSCPs), and Periodic Safety Update Reports (PSURs).[/fusion_text][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”22764|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Key Features of CAPTIS” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/02/AI-Powered-Systematic-Literature-Reviews-Faster-More-Efficient-iblog.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How CAPTIS^® Enhances CER Development

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”^®” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Using CAPTIS^® in CER offers multiple advantages. CAPTIS^® helps to manage the vast amount of source documents required to add the data in the sections, literature search and database integration like Adverse Event (AE) database integration and an automated template where the common data like device name is automatically filled in the CER leading to substantial time saving. The template in CAPTIS^® can also be modified and is downloadable at any point during creation of the document.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”^®^®” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Key CAPTIS^® Features for CER Efficiency

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]As with the interface being straightforward and easy to navigate and the use of templates and automated literature reviews, it is ensured that information is presented consistently across all documents. The automated literature module integrates seamlessly with databases like PubMed and Google Scholar which helps in easy retrieval and screening of relevant literature in turn reducing manual effort. The platform also integrates with AE databases like MAUDE, TPLC which are a major part of risk analysis for the CER.

Additionally, CAPTIS^® also helps in the editorial side of the document, ensuring use of predefined templates, automatic creation of abbreviation tables, keyword dictionary etc. Last but not least, CAPTIS^® also provides features for commenting, version control, and centralized documentation, facilitating collaboration among team members and ensuring that all contributions are traceable and auditable.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”18px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Streamlining Regulatory Compliance with CAPTIS^®

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

These features substantially decrease manual effort and chances of error, thereby increasing the efficiency and accuracy of CERs. This makes it easier for manufacturers to create complex regulatory documents for their medical devices.

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filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy” admin_toggled=”yes”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ padding_top=”0″ margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” min_height=”” link=””][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”22759|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”AI-Powered Systematic Literature Reviews: Faster & More Efficient” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/02/AI-Powered-Systematic-Literature-Reviews-Faster-More-Efficient-cover.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How AI Speeds Up Systematic Literature Reviews by 60%

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Systematic Literature Reviews (SLR), also known as Literature Search Reviews (LSR), play a vital role in ensuring compliance with stringent regulations such as the EU MDR. However, the traditional process of conducting SLRs, often performed by Medical and Clinical Affairs teams manually, is the most time-consuming and labor-intensive component of CERs. Enter AI-powered solutions, which are revolutionizing the way we approach SLRs, speeding up the process by an impressive 60%.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”24px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

The Challenge of Systematic Literature Reviews

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Systematic Literature Reviews are essential for compiling Clinical Evaluation Reports (CER) and meeting regulatory requirements. These reviews involve meticulously searching, screening, and analyzing vast amounts of scientific literature to ensure that medical devices are safe and effective. The process is not only time-consuming but also requires a high level of accuracy and attention to detail.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”24px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

How AI is Transforming SLRs

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]AI-powered tools are changing the game by automating many of the labor-intensive tasks involved in SLRs. For instance, AI can quickly search and screen literature, identify relevant studies, and even extract data, significantly reducing the time and effort required. With a direct connection to databases, integration into the Literature Module, automations, simultaneous review by multiple reviewers, and other features, AI makes this tedious process immensely easier, taking the burden off SMEs.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”24px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Benefits of AI in SLRs

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AI tools can process large volumes of data much faster than humans, reducing the time required for literature searches and reviews. AI algorithms can identify relevant studies with high precision, minimizing the risk of missing important information. AI ensures that the review process is consistent and reproducible, which is crucial for regulatory compliance. By automating repetitive tasks, AI reduces the need for manual labor, leading to cost savings.

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Challenges Faced Before Using CAPTIS®

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Before the introduction of CAPTIS®, our medical writers and regulatory professionals faced several challenges in conducting SLRs. The traditional process was highly manual, involving extensive literature searches, data extraction, and documentation. This often led to:

• Time Constraints: The manual nature of the process meant that literature reviews could take weeks or even months to complete, putting pressure on teams to meet tight deadlines.
• Data Management: Handling vast amounts of data from multiple sources was cumbersome and prone to errors. Ensuring the accuracy and consistency of the data was a significant challenge.
• Collaboration Issues: Coordinating efforts among team members was difficult, with feedback and updates often getting lost in lengthy email chains or disparate documents.
• Regulatory Compliance: Meeting the stringent documentation requirements of regulatory bodies required meticulous attention to detail, which was time-consuming and labor-intensive.

[/fusion_text][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”22764|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Key Features of CAPTIS” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/02/AI-Powered-Systematic-Literature-Reviews-Faster-More-Efficient-iblog.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”24px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Celegence’s Approach to AI-Powered SLRs

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At Celegence, we leverage our in-house AI medical writing platform, CAPTIS®, to streamline the SLR process. CAPTIS Copilot, an AI integration within the Literature module, automatically extracts relevant information from research articles such as study type, study subjects, demographics, interventions used, and adverse events. This information is summarized within seconds, allowing medical writers to be more efficient and consistently meet deadlines.

From literature search to screening and appraisal, CAPTIS® enables seamless collaboration and communication among team members. “From the literature search to the screening and appraisal performed on the platform and the documents that have been authored on CAPTIS, I can collaborate and communicate with the author and leave my feedback on the platform itself. The author can request for verification of actions performed and I can provide my updates after my review,” Celegence medical writer explained.

The data dictionary and automated reports generated by CAPTIS® make the review process more effective and the content more accurate. The content linking feature allows users to cross-verify data from source documents with just one click. Additionally, multiple reviewers can review a single document simultaneously, bringing efficiency to the process. “The features of data dictionary and automated reports that have been generated make the review process more effective and the content added more accurate. The content linking feature allows me to cross-verify the data that’s been added from the source documents in just one click. Multiple reviewers can review a single document simultaneously which brings efficiency to the process,” the medical writer added.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”24px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Conclusion

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AI is transforming the way we conduct Systematic Literature Reviews, making the process faster, more accurate, and more efficient. By leveraging AI-powered tools like CAPTIS®, medical device professionals can ensure compliance with regulatory requirements while saving time and resources. Stay ahead of the curve by embracing AI in your SLR process. See how our AI-powered solutions can transform your regulatory processes. Contact us at info@celegence.com to learn more.

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stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2025/01/Benefit-Risk-Analysis-for-EU-MDR-cover.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” 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Mastering Benefit-Risk Analysis for EU MDR Compliance

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Benefit-risk analysis is a cornerstone of compliance for medical device manufacturers under the EU MDR. This rigorous process evaluates whether the benefits of a device outweigh its associated risks, ensuring patient safety and regulatory approval. With the increasing complexity of medical devices and evolving regulations, understanding and implementing effective benefit-risk analysis is critical.

But what does it take to successfully navigate these complexities? In this blog, we delve into insights shared during a recent webinar to explore key methodologies, tools, and best practices to excel in this domain.

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Understanding Benefit-Risk Analysis

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Benefit-risk analysis is not a one-time activity but a continuous process integrated throughout a device’s lifecycle. Its primary goal is to demonstrate that the benefits of a device significantly outweigh its risks, thereby justifying its acceptability for patient use. Key regulatory frameworks guiding benefit-risk assessments include:

• EU MDR Article 2 and GSPR 2 and 8: These articles outline essential definitions and data presentation requirements for demonstrating acceptability.
• ISO 14971: Offers comprehensive guidelines for risk management, including identifying, assessing, and mitigating risks.
• MDCG 2026 Guidance: Provides clinical evaluation pathways for effective benefit-risk analysis.
• MedDev 2.7.1 Revision 4: Offers examples and distinctions between qualitative and quantitative assessments.

By aligning benefit-risk analysis with these frameworks, manufacturers ensure their devices meet regulatory expectations while prioritizing patient safety. Now, let’s take a closer look at the key components that form the foundation of an effective benefit-risk assessment.

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Key Components of Benefit-Risk Analysis

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An effective benefit-risk analysis revolves around several fundamental components:

• Benefit: Represents the positive impact on patient health, such as improved diagnosis, management, or treatment outcomes. Benefits can be direct (e.g., life-saving interventions) or indirect (e.g., aiding clinicians in decision-making).
• Risk: Combines the probability of harm occurring with the severity of that harm. Risks could range from mild side effects to serious adverse events.
• Residual Risk: The remaining risk after mitigation measures have been applied. It’s crucial to acknowledge and document these risks transparently.
• Benefit-Risk Ratio: A comparative measure that evaluates whether the benefits justify the associated risks, expressed in qualitative or quantitative terms.

These components provide the building blocks for a robust analysis. But why is this process so important for manufacturers and regulators alike? Let’s explore the broader significance of benefit-risk analysis.

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Why Benefit-Risk Analysis Matters

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Conducting a robust benefit-risk analysis is crucial for several reasons:

1. Ensuring Patient Safety – The primary purpose of medical devices is to enhance patient outcomes. Benefit-risk analysis ensures that devices provide more good than harm, identifying potential risks and addressing them proactively. This approach is an ethical obligation for manufacturers and healthcare providers alike.
2. Regulatory Compliance -Under the EU MDR, benefit-risk analysis is a mandatory component of Clinical Evaluation Reports (CERs) and risk documentation. Regulators demand detailed justifications of the benefit-risk profile, supported by clinical evidence, to approve devices for market use. A weak analysis could result in delays or rejections.
3. Informed Decision-Making – Benefit-risk assessments provide valuable insights for clinicians and patients, enabling informed choices. For example, identifying contraindications or subpopulations where a device’s risks outweigh its benefits helps tailor its use to appropriate cases.
4. Facilitating Continuous Improvement – Real-world performance data collected post-market can highlight areas for improvement. Benefit-risk analysis allows manufacturers to refine device design, labeling, or risk control measures to align with state-of-the-art practices and maintain a competitive edge.

Understanding the importance of benefit-risk analysis sets the stage for examining the methodologies that bring it to life. How do manufacturers choose the right approach for their devices? Let’s explore.

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Methodologies for Benefit-Risk Analysis

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Benefit-risk analysis can be conducted using qualitative or quantitative approaches, depending on the device’s risk class, clinical data availability, and intended use. Let’s explore these methodologies in detail

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1. Qualitative Analysis

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Qualitative analysis relies on descriptive terms rather than numerical data to evaluate benefits and risks. This approach is ideal for low-risk devices or those with indirect benefits. Examples include:

• Devices with Indirect Benefits: Diagnostic tools or assistive devices that support better decision-making for clinicians.
• Procedural Efficiency: Devices improving healthcare workflows or reducing recovery times.

Common Parameters in Qualitative Analysis

• End-User Benefits: How the device supports healthcare providers or caregivers.
• Quality of Life Improvements: Enhancements in patient well-being due to reduced recovery times or improved procedural outcomes.
• Minor Risks: Usability challenges or procedural complications that are easily manageable.

Example: A wound bandage’s qualitative analysis might highlight benefits like enhanced healing environments while documenting minor risks such as skin irritation.

For devices with higher complexity or risk, however, qualitative analysis may not suffice. This brings us to quantitative methodologies.

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2. Quantitative Analysis

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Quantitative analysis employs statistical and numerical methods to provide a data-driven evaluation of benefits and risks. This method is crucial for high-risk devices where objective evidence is essential.

Techniques for Quantitative Analysis

• Benefit-Risk Ratio: Compares the frequency and severity of benefits versus risks.
• NNT (Number Needed to Treat) vs. NMH (Number Needed to Harm): Calculates how many patients need treatment to observe one benefit or one harm, respectively.
• QALY (Quality Adjusted Life Years): Quantifies both the quality and duration of life improvements a device offers.

Example: For a cardiac stent, if the NNT is 25 (indicating significant benefit) and the NMH is 200 (indicating low harm likelihood), the device’s favorable profile supports its use.

Both approaches play a critical role in addressing the challenges manufacturers face during regulatory submissions. Let’s examine common hurdles and how to overcome them.

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Challenges Highlighted by Notified Bodies

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Notified bodies frequently flag common shortcomings in benefit-risk assessments, such as:

• Insufficient Clinical Evidence: Broad claims unsupported by targeted, robust data.
• Incomplete Risk Characterization: Missing details about risk severity, likelihood, or affected patient populations.
• Over-Reliance on Qualitative Analysis: Lack of quantitative insights to substantiate benefit-risk profiles for high-risk devices.
• Documentation Inconsistencies: Misalignment across CERs, risk management files, and post-market surveillance reports.

By addressing these gaps, manufacturers can strengthen their submissions and ensure alignment with regulatory expectations.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Celegence’s Role in Simplifying Benefit-Risk Analysis

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Celegence leverages innovative tools like CAPTIS® to streamline the benefit-risk assessment process. CAPTIS integrates:

• Literature reviews and adverse event data.
• Automated alerts for document updates.
• Advanced search capabilities for discrepancy detection.

By centralizing data and automating workflows, CAPTIS saves time, reduces errors, and ensures comprehensive regulatory submissions. With these tools, manufacturers can focus on delivering safe and effective devices without getting bogged down in complex processes.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Conclusion

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Benefit-risk analysis is integral to both patient safety and regulatory success under the EU MDR. By employing the right methodologies—whether qualitative or quantitative—and leveraging cutting-edge tools, manufacturers can confidently navigate regulatory challenges and demonstrate their commitment to delivering safe and effective medical devices.

The question now is: Are you equipped to master your benefit-risk analysis? Contact Celegence to learn how we can support your regulatory needs.

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Make Sure You’re EU MDR Compliant

Download our EU MDR checklist for actionable technical documentation requirements. The checklist highlights all the key areas that you need to be aware of and serves as a guide to help get you EU MDR compliant. In conjunction with this checklist, we are also able to provide you with bespoke plans on how to get your business up to speed. Celegence provides expertise for every step of the Medical Device product lifecycle management for RA, QA and Clinical Departments of Medical Device companies.

Download Your EU MDR Checklist

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first=”true”][fusion_imageframe image_id=”22086|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Implementing Maintaining PMS Performance Evaluation IVDR – Q&A – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ 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title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]AI and Automation Tools: Medical Writers’ Point of View[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help?

AI-driven tools and automations enhance productivity, ensure consistency, and simplify the complex regulatory processes, allowing professionals to focus on analytical work instead of repetitive tasks.

Celegence has interviewed medical writers and asked them about practical advantages of such technologies. Here is what they shared about their experience using CAPTIS® medical writing platform:

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type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” 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Q: How does a medical writing platform improve your day-to-day as a medical writer?

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A: Workflow is significantly improved by centralizing all reference documents, literature search results, and automated reports in one place. It also means data is easily traceable. Its customized templates save time and streamline periodic updates, helping manage complex regulatory requirements more efficiently.

One of the standout features is its ability to configure style templates, ensuring that all content, tables, figures, headers, and footers are automatically formatted and consistent when exported to Word. Medical writers can rely on CAPTIS® for the mechanical aspects of writing, freeing them to focus on the analytical process.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Q: How does it help maintain consistency in information throughout various documents such as the CER, SSCP, etc.?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]A: Features such as the user-friendly interface and data dictionary ensure consistency in critical data and text, while the ability to leave comments and feedback across all modules helps maintain accuracy in documents.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Q: How can the device industry keep up with the resource challenges posed by EU MDR & IVDR?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]A: Increased documentation requirements under the EU MDR & IVDR are putting a strain on our industry’s expert resources. To prevent burnout and make better use of our skilled teams, investing in technological solutions is crucial, as it alleviates pressure through automation and AI. With the ability to modify and augment archived search strings, results, and screenings, document maintenance is streamlined and highly efficient.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Q: How does AI save up to 60% of time on literature search reviews?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

A: By linking directly to multiple databases and allowing uploads from others, literature reviews are far more efficient and accurate than a manual process. The AI-enabled literature module, known as CAPTIS® Copilot, automatically extracts and summarizes relevant information from research articles in seconds. This significantly reduces research workload and helps writers consistently meet deadlines.

Among other things, it’s designed with input from medical writers. The platform addresses specific pain points like automatic generation of abbreviations, PRISMA flow charts, and automatic contents table updates.

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”yes” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Q: How do you now perform regulatory audits?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

A: CAPTIS® provides a single source of truth, systematically collating and analyzing data to minimize non-conformances and streamline the certification process. With the AI feature writers have confidence that they can quickly find the information they need, supporting data analysis, and enhancing the quality of their documents.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Q: How does the citation manager tool work?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

A: By enabling collaboration with other authors and reviewers, the whole process is more productive. Other features, such as the data dictionary, automated reports, and content linking, enhance the review process and ensure that content is accurate.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Q: How do you review documents and collaborate?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]A: By enabling collaboration with other authors and reviewers, the whole process is more productive. Other features, such as the data dictionary, automated reports, and content linking, enhance the review process and ensure that content is accurate.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”yes” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Watch the full interview here

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Want to explore how CAPTIS® can streamline your workflow and enhance your productivity? Visit Celegence website to arrange a consultation or a demo.

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For more information on how we can help you with EU MDR requirements reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.

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