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

15 Apr, 2025

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

Why Choose Celegence for Your Benefit-Risk Analysis?

Medical writers often struggle with:

Scattered Data Sources: Managing literature references, risk assessments, and extracted data across multiple systems is inefficient.
Manual Data Extraction: Identifying risks and adverse events from literature takes time and is prone to human error.
Cumbersome Adverse Event Searches: Searching the FDA’s MAUDE database is a manual, fragmented process.
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.

How Celegence Uses CAPTIS® to Achieve Efficiency

- 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:
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.
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.
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.

Why Work With Celegence?

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

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

03 Apr, 2025

Enhancing Systematic Literature Reviews for Adverse Events with AI

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.

Challenges in Conducting SLRs

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.

Leveraging Advanced Tools for SLRs

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

Case Study: AI-Powered SLRs at Celegence

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.

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Driving Safer, Smarter Reviews with AI-Powered Precision

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®

24 Mar, 2025

Clinical Evaluation Report Template and CAPTIS^®

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).

Key Documents in the Clinical Evaluation Process

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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Structure and Content of a Clinical Evaluation Report

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

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).

How CAPTIS^® Enhances CER Development

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.

Key CAPTIS^® Features for CER Efficiency

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.

Streamlining Regulatory Compliance with CAPTIS^®

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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How AI Speeds Up Systematic Literature Reviews by 60%

04 Feb, 2025

How AI Speeds Up Systematic Literature Reviews by 60%

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%.

The Challenge of Systematic Literature Reviews

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.

How AI is Transforming SLRs

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.

Benefits of AI in SLRs

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.

Challenges Faced Before Using CAPTIS®

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.

Celegence’s Approach to AI-Powered SLRs

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.

Conclusion

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.

Mastering Benefit-Risk Analysis for EU MDR Compliance

24 Jan, 2025

Mastering Benefit-Risk Analysis for EU MDR Compliance

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.

Understanding Benefit-Risk Analysis

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.

Key Components of Benefit-Risk Analysis

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.

Why Benefit-Risk Analysis Matters

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

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.
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.
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.
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.

Methodologies for Benefit-Risk Analysis

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:

1. Qualitative Analysis

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.

2. Quantitative Analysis

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.

Challenges Highlighted by Notified Bodies

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.

Celegence’s Role in Simplifying Benefit-Risk Analysis

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.

Conclusion

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.

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

Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

28 Nov, 2024

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:

Q: How does a medical writing platform improve your day-to-day as a medical writer?

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.

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

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.

Q: How can the device industry keep up with the resource challenges posed by EU MDR & IVDR?

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.

Q: How does AI save up to 60% of time on literature search reviews?

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.

Q: How do you now perform regulatory audits?

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.

Q: How does the citation manager tool work?

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.

Q: How do you review documents and collaborate?

Watch the full interview here

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

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.

Why Clinical Evaluation Reports (CERs) are Challenging and How Celegence Can Streamline the Process

10 Oct, 2024

Clinical Evaluation Reports (CERs)

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device Regulation (EU MDR) is mandatory. These reports serve as documented evidence to establish that a medical device meets the required safety and performance standards.

However, for many manufacturers, preparing and maintaining CERs can be a daunting task. From navigating ever-evolving regulatory requirements to conducting rigorous literature reviews, the process of creating a CER is resource-intensive and often overwhelming. In this blog, we explore why CERs present such significant challenges to medical device companies and how Celegence can help streamline the process with expert consulting services and innovative solutions.

Why are CERs considered Problematic?

Navigating Complex and Evolving Regulatory Requirements: One of the biggest challenges in creating CERs is staying up-to-date with the ever-changing regulatory landscape. Different markets have specific regulations, and these go through updates quite often, which add additional complexity to the process. For instance, with the introduction of the EU MDR, the requirements for clinical data have become more stringent, making it difficult for manufacturers to maintain compliance without constant regulatory vigilance and post market surveillance (PMS).

It is the expectation that manufacturers need to continuously monitor any updates to the regulations that are applicable to their devices, any guidance documents that may have to be referred to, and expectations from the Notified Bodies based on previous review experiences. As stated earlier, the EU MDR has heightened the requirements for robust and relevant clinical evidence, particularly for higher-risk devices. There is an increased demand and expectation for post-market clinical follow-ups (PMCF) and systematic evaluations of clinical data, which adds an additional layer of complexity to an already complicated process.

The process of gathering sufficient clinical data for a CER is often one of the most challenging aspects for medical device manufacturers. Many devices, especially legacy devices, and low-risk devices, may lack the clinical data required by the current regulatory standards. Moreover, the collection of high-quality, robust, relevant, and up-to-date clinical data can be a time-consuming and costly endeavor.

Another critical component of CERs is the systematic literature review process. Conducting a comprehensive review that meets regulatory standards requires specialized skills and access to extensive databases. Even then, ensuring that the literature review is thorough and includes all relevant data points can be a significant hurdle. For medical devices that have been on the market for several years, as well as for low-risk devices, and devices used in conjunction with other medical devices, it can be especially difficult to find relevant studies or clinical and technical data that align with the product’s intended use and safety profile.

Creating a CER is not a one-time activity; it requires ongoing efforts to assess relevant clinical data, maintain compliance, update reports, and respond to regulatory body feedback. The process demands a combination of specialized knowledge in regulatory affairs, clinical research, and literature analysis, making it a resource-intensive process for manufacturers.

Furthermore, manufacturers must ensure that the content presented in their CERs are consistent across all documentation that are to be submitted to the Notified Bodies. This means, there is the expectation of close attention to detail, and frequent updates as and when new clinical data becomes available. The need for resources to perform these activities, whether internal or through outsourcing, can place a considerable burden on small to medium-sized manufacturers, who often lack the internal bandwidth to manage these tasks effectively.

How long does it take to create a CER?

The timeline to author and develop a CER depends on multiple factors; most essentially the risk classification of the devices, the amount of available data (both internal and external), whether the device is already established or new to the market, etc. Based on Celegence’s experience, the example depicted below presents a standard timeline that is required for developing a CER.

As per MEDDEV 2.7.1 Rev 4, clause 6.2.3, a CER is required to be updated at least annually for high-risk or newly established devices, and every 2 to 5 years for lower risk, well-established devices. This frequency also varies in the following scenarios:

New information is received from the post market surveillance that has the potential to change the current evaluation process;
Any updates to the design of the device or manufacturing process which impacts the safety and performance of the medical device;
Any new risks identified from literature or other sources of data that affect the safety and performance of the device.

Based on the parameters stated above, the manufacturer must decide the frequency of update of the CERs.

How Celegence Can Help Simplify the process of CER Development

At Celegence, we understand the complexities associated with navigating the regulatory landscape for medical devices. Our team of experts offer tailored consulting services to help medical device manufacturers meet regulatory requirements efficiently. Whether your organization is struggling with data collection, literature reviews, or regulatory submissions, our consultants can guide you and provide the expertise you need.

We specialize in helping clients comply with the most stringent requirements under EU MDR. By partnering with Celegence, you gain access to a team of regulatory professionals who stay up to date with the latest industry regulations and Notified Body expectations. This ensures that your CERs are not only compliant but also tailored to meet the specific needs of your medical device based on the risk classification and market.

AI-Enabled Tools for Efficient Systematic Literature Review

One of the standout features of Celegence’s service offering is our AI-enabled systematic literature review solution. Traditional literature reviews are time-consuming and prone to human error. Our AI-powered tools streamline the data extraction process, enabling faster and more accurate reviews, while reducing the burden on your internal resources.

With Celegence’s technology, medical device manufacturers can focus on clinical data that truly matters. Our AI algorithms sift through thousands of documents to identify the most relevant studies and data points, ensuring a more efficient and thorough literature review. This ultimately helps speed up the CER development process, allowing companies to submit their reports faster and with greater confidence with respect to the accuracy and comprehensiveness of the data.

Tailored Solutions for Medical Device Manufacturers

No two medical device manufacturers are the same, and neither are their regulatory needs. To address this individualistic requirement, Celegence offers tailored solutions which combat the unique challenges faced by our clients. Whether you need assistance with the entire CER process or just specific aspects like literature reviews or post-market clinical follow-ups (PMCF), Celegence provides flexible and scalable solutions that can be adapted to your needs.

In addition to providing regulatory consulting and literature review services, Celegence helps manufacturers reduce compliance costs over time. We work with your internal teams to optimize the CER development process, implement cost-effective solutions, and provide insights into how our AI-enabled software can further streamline compliance efforts.

Conclusion: Streamlining CERs for Faster Market Access and Regulatory Success

Creating and maintaining compliant CERs is both challenging and resource-intensive, requiring manufacturers to balance stringent regulatory demands with efficiency. However, these hurdles can be overcome with the right expertise and tools.

Partnering with Celegence provides you access to skilled and experienced regulatory consultants, AI-driven solutions, and access to tailored support, to streamline your CER process. From navigating complex regulations to conducting systematic literature reviews, our specialists ensure your CERs are compliant with EU MDR requirements, enabling faster regulatory approvals and confident market entry.

Are you facing challenges with your Clinical Evaluation Reports? Contact Celegence today to learn how we can help you navigate the complexities of CER preparation and ensure regulatory success.

Make Sure You’re EU MDR Compliant

Download Your EU MDR Checklist

New FDA Regulations for Laboratory Developed Tests (LDTs): What It Means to Laboratories

29 Aug, 2024

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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=””]New FDA Regulations for Laboratory Developed Tests (LDTs)[/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=””]As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations mean for laboratories developing and selling LDTs and how Celegence can support compliance.[/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=”” 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 Are the New FDA Regulations Important for LDTs?[/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=””]Historically, laboratory Quality Management System (QMS) requirements have been governed by CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists). The new FDA regulations introduce stricter compliance measures, requiring laboratories to meet the FDA Medical Device QMS requirements outlined in 21 CFR 820.[/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” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ 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_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” 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=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ 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″ 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_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=””]

Key Changes Under the New FDA LDT Regulations

Stage 1: By May 6, 2025 – Laboratories must update their QMS to include adverse event reporting, reporting of corrections and removals, and establishing a complaint file.
Stage 2: By May 6, 2026 – Compliance extends to completing a registration and device listing, updating regulatory labeling, and adhering to investigational use requirements.
Stage 3: By May 6, 2027 – Full QMS updates are required, incorporating design controls, purchasing controls, acceptance activities, CAPA (Corrective and Preventive Actions), and comprehensive record-keeping.
FDA Submissions: 2027 or 2028 – Depending on the LDT’s risk classification, submissions to the FDA must be made by November 6, 2027, for PMA (Premarket Approval) pathway tests or by November 6, 2028, for tests following the 510(k) or De Novo pathways.

[/fusion_text][fusion_imageframe image_id=”20720|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Timeline for New FDA LDT Regulations – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/08/Timeline-for-New-FDA-LDT-Regulations-Celegence.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=”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=””]Immediate Steps for LDT Compliance[/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=””]

Adverse Event Reporting
Labs need to develop robust systems to report any adverse events to the FDA. For instance, if a specimen collection device causes a patient rash, this incident must be reported.

Corrections and Removals
Procedures must be established for reporting corrections and removals. If a lab test result is voided due to a lab error, it falls under this category and must be documented accordingly.

Complaint File Management
Laboratories must maintain a complaint file, tracking and resolving complaints made directly or found on social media and other platforms. For example, an Instagram post from a patient claiming a lab test error must be addressed per FDA regulations.

LDT Legal Challenges and Industry Concerns

[/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=””]The American Clinical Laboratories Association (ACLA) has raised concerns, filing a lawsuit against the FDA, arguing that the new regulations overstep the FDA’s authority. While this legal battle unfolds, laboratories must prepare for compliance, as significant changes will require substantial investment, particularly for FDA submissions scheduled in 2027 or 2028.[/fusion_text][fusion_imageframe image_id=”20721|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”LDT Legal Challenges and Industry Concerns” 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/08/LDT-Legal-Challenges-and-Industry-Concerns.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=”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=””]

Strategic Preparation for LDT Compliance

Start with a Gap Assessment
Celegence recommends conducting a gap analysis to assess your current QMS against FDA requirements. Early identification of compliance gaps allows for a smoother transition to meeting new standards.

Phased Implementation
Gradually implement new procedures to bridge gaps in compliance. This approach minimizes disruption and helps laboratories adjust to new requirements over 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=”” 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=””]Staying Ahead: Why Early LDT Compliance Matters[/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=””]

While some laboratories might consider delaying compliance efforts due to ongoing legal challenges, early preparation offers several advantages:

Cost Efficiency: Bridging QMS gaps early involves relatively low investment compared to the potential costs of last-minute changes.
Risk Mitigation: Proactive compliance reduces the risk of penalties, product recalls, and market disruptions.
Regulatory Assurance: By aligning with FDA requirements, laboratories can confidently offer LDTs that meet the highest standards of safety and quality.

[/fusion_text][fusion_imageframe image_id=”20731|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Your Partner in LDT Regulatory Compliance – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/08/Your-Partner-in-LDT-Regulatory-Compliance-Celegence.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=”” 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=””]

Your Partner in LDT Regulatory Compliance

Comprehensive Gap Analysis: Identify your current QMS compliance gaps.
Tailored Compliance Plans: Develop and implement strategies to meet FDA’s phased requirements.
Expert Guidance on FDA Submissions: Assistance with FDA submissions, labeling revisions, and technical file remediation.

For more information on how Celegence can help your laboratory achieve seamless compliance with the new LDT regulations, email us at at info@celegence.com or contact us online.[/fusion_text][fusion_text rule_style=”default” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″]

Make Sure You’re EU IVDR Compliant

The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.

Download Your EU IVDR Checklist

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About The Author

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animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”false”][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=”20px” 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=””]This blog was authored by Joy Greidanus, Director SME – Medical Device Services. She has a strong experience and expertise that includes US submissions, collaborative interaction with FDA, strategies for medical device pre-market notifications, IDE applications, clinical trial notifications, research ethics committee submissions, developing/maintaining technical files and design dossiers, international marketing authorizations, risk management, design control, and regulatory compliance.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Mastering PMCF and PMPF for Regulatory Compliance

14 Aug, 2024

Post-Market Clinical Follow-up (PMCF) is a specific type of post-market surveillance (PMS) activity that involves collecting clinical data after a medical device has been placed on the market. This data helps assess the device’s long-term safety and effectiveness in real-world 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=”” 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=”” 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 Role of Post-Market Performance Follow-up (PMPF) in 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=””]Post-Market Performance Follow-up (PMPF) is a broader concept under the In Vitro Diagnostics Regulation (IVDR) that encompasses the continuous monitoring and evaluation of an In Vitro Diagnostic (IVD) device’s performance throughout its lifecycle.

Objectives of PMCF and PMPF: Both PMCF and PMPF aim to ensure the device’s continued performance meets its intended purpose and the benefit-risk profile remains acceptable.[/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” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ 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_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” 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=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ 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″ 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_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=””]

Strategy for Drafting PMCF & PMPF Plans and Reports

Define Objectives: Clearly articulate the specific aims of the PMCF/PMPF plan. Detail which safety and performance aspects of the device will be monitored.
Identify Data Sources: Specify the origins of data to be gathered, such as clinical trial results, registries, complaints, and feedback from healthcare providers.
Data Collection Methods: Establish a robust framework for collecting and analysing data to ensure its integrity and traceability.
Risk Assessment: Continually evaluate risks identified during pre-market assessment and any emerging risks using post-market data with ongoing risk management.
Periodic Reporting: Regularly compile reports summarizing collected data, trends identified, and any corrective measures deemed necessary.

[/fusion_text][fusion_imageframe image_id=”20682|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Strategy for Drafting PMCF & PMPF Plans and Reports” 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/08/Strategy-for-Drafting-PMCF-PMPF-Plans-and-Reports.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=”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=””]Methods for Conducting Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) Studies[/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=””]

General Methods

General methods for assessing the performance of a medical device in real-world-use involve gathering information from various sources. Here are some examples:

Clinical Experience: This involves collecting data on the device’s performance in clinical practice. Methods include retrospective or prospective chart reviews of patients who have used or have been treated using procedures where the device was in use.

Scientific Literature Review: Reviewing published studies and conducting systematic literature reviews on the device can help identify emerging safety or performance issues.

Specific Methods for PMCF

PMCF studies and surveys focus specifically on collecting clinical data, so let’s delve into those methods.

User Feedback: Insights from healthcare providers and patients who use the device are valuable for evaluating its performance. This feedback can be obtained through surveys, focus groups, and complaint-reporting systems.

New Interventional Studies: These can be designed in various ways, including:

Registries: Collecting data from a specific patient population using the device.
Patient Reported Outcomes: Using surveys or questionnaires to gather information directly from patients about their experience with the device.
Physician-Reported Outcomes: Data are collected from healthcare providers on their observations of the device’s effectiveness and safety in their patients.

Specific Methods – PMPF

Ring Trials: Controlled studies where a group of healthcare providers use the device in a specific setting and report on their experiences.

Epidemiological Studies: Assessing the long-term safety and effectiveness of a device in a large population.

Quality Assurance Activities: Utilizing existing quality assurance programs to collect data on device performance, including information on adverse events, complaints, and malfunctions.[/fusion_text][fusion_imageframe image_id=”20679|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Common Pitfalls of PMCF and PMPF – Patient Recruitment – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/08/Common-Pitfalls-of-PMCF-and-PMPF-Patient-Recruitment-Celegence.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=”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=””]

Common Pitfalls of PMCF and PMPF

Misinterpretation Observed with PMCF, PMPF, and PMS

PMCF and PMPF are distinct activities within the broader PMS system. Some manufacturers might erroneously consider them interchangeable, resulting in an incomplete PMS plan.

Study Design

Unrealistic Objectives: PMCF studies must have well-defined, achievable objectives that align with the device’s risk profile. Setting overly ambitious goals can lead to wasted resources and inconclusive data.

Poor Methodology: Selecting an inappropriate study design, such as using retrospective analysis when prospective data is required, can hinder the ability to draw meaningful conclusions regarding the device’s performance.

Study Subjects

Limited Patient Pool: The study population may not accurately represent real-world usage, potentially overlooking important safety signals from specific patient subgroups.

Ethical Considerations: Neglecting to adequately address ethical considerations and obtain informed consent from participants can lead to regulatory issues.

Patient Recruitment

Low Enrolment Rates: Challenges in recruiting sufficient participants can delay or disrupt the study, delaying data collection.

Site Selection Bias: Selecting sites with limited experience on the device or its target patient population can undermine the study’s wider applicability.

Unclear Risk Assessment and PMCF Objectives

Failing to clearly communicate the device’s risk profile and the rationale behind the chosen PMCF/PMPF plan can raise questions from Notified Bodies.

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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/2024/08/Comprehensive-PMCF-and-PMPF-Services-Celegence.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=”” 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=””]Comprehensive PMCF and PMPF Services[/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=””]

At Celegence, we recognize the vital importance of PMCF and PMPF in medical device and IVD manufacturing. As a specialized regulatory services company, we empower manufacturers to navigate the complexities of PMCF/PMPF and ensure compliance with regulatory requirements. Our comprehensive suite of services related to post-market activities, offers value through:

Strategic Planning and Gap Analysis
Draft Plan & Report Preparation
Data Management and Reporting
Regulatory Liaison and Communication
Quality Management System Integration

Our expertise helps you navigate the intricacies of post-market activities, allowing manufacturers to concentrate on patient safety and continuous product improvement.

To find out more about how we can help you with your PMCF and PMPF then reach out to us at info@celegence.com or contact us online for more information.

References

[/fusion_text][fusion_text rule_style=”default” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″]

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[/fusion_title][/fusion_builder_column][fusion_builder_column type=”1_4″ layout=”1_4″ align_self=”auto” content_layout=”column” align_content=”flex-start” valign_content=”flex-start” content_wrap=”wrap” spacing=”” center_content=”no” column_tag=”div” link=”” target=”_self” link_description=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” type_medium=”” type_small=”” flex_grow_medium=”” flex_grow_small=”” flex_grow=”” flex_shrink_medium=”” flex_shrink_small=”” flex_shrink=”” order_medium=”0″ order_small=”0″ spacing_left_medium=”” spacing_right_medium=”” spacing_left_small=”” spacing_right_small=”” spacing_left=”” spacing_right=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” padding_top_medium=”” padding_right_medium=”” padding_bottom_medium=”” padding_left_medium=”” padding_top_small=”” padding_right_small=”” padding_bottom_small=”” 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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″ filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ transform_type=”regular” transform_hover_element=”self” transform_scale_x_hover=”1″ transform_scale_y_hover=”1″ transform_translate_x_hover=”0″ transform_translate_y_hover=”0″ transform_rotate_hover=”0″ transform_skew_x_hover=”0″ transform_skew_y_hover=”0″ transform_scale_x=”1″ transform_scale_y=”1″ transform_translate_x=”0″ transform_translate_y=”0″ transform_rotate=”0″ transform_skew_x=”0″ transform_skew_y=”0″ transform_origin=”” transition_duration=”300″ transition_easing=”ease” transition_custom_easing=”” motion_effects=”W10=” scroll_motion_devices=”small-visibility,medium-visibility,large-visibility” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”false”][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=”20px” 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=””]This blog was authored by Prasad Ravichandran, a Team Lead in Medical Device Regulatory Affairs at Celegence. Prasad is a Certified Lead Auditor for ISO 13485:2016, with extensive experience in medical devices and IVD technical documentation submission, CDSCO registration, and securing wholesale and import licenses. He is also an experienced clinical research auditor.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Harmonizing ISO 14971:2019 and FDA QMSR for Medical Device Safety

31 Jul, 2024

In February 2024, The United States Food and Drug Administration (USFDA) implemented the Quality Management System Regulation (QMSR), marking a significant shift in its approach to medical device oversight. The QMSR replaces the previous Quality System Regulation (QSR) with a more risk-based framework. This signifies a fundamental change in the regulatory philosophy, aligning with international standards like ISO 13485 and ISO 14971:2019.

[/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=”” 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=””]Importance of Risk Management for Medical Devices and IVDs[/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=””]

Ensuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

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To maintain a robust Quality Management System (QMS) that incorporates risk management principles is outlined in ISO 14971:2019. This ensures that risk assessment and mitigation strategies are embedded throughout the entire product lifecycle, from design and development to manufacturing and post-market surveillance.

Emphasizing Risk Management in FDA QMSR

By adopting ISO 13485, the QMSR integrates risk management principles throughout its requirements. This means that risk management activities and risk-based decision making are explicitly emphasized as crucial elements of an effective quality management system. This emphasis is evident in various clauses of ISO 13485, including but not limited to 4.1, 7.1, 7.3, 7.4, 7.5, 7.6, and 8.2, along with certain subclauses within these clauses.

[/fusion_text][fusion_imageframe image_id=”20578|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Emphasizing Risk Management in FDA QMSR – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/07/Emphasizing-Risk-Management-in-FDA-QMSR-Celegence.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=”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=””]Strategies for Aligning the QMSR with 14971-2019[/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=””]

Risk Management Lifecycle

All-inclusive Approach: Ensure risk management is integrated throughout the entire product lifecycle, from design and development to manufacturing, post-market surveillance, and risk control activities.
Continuous Improvement: Regularly review and update risk assessments based on post-market data, complaints, and adverse event reports. This promotes a proactive approach to identifying and mitigating emerging risks.

Risk-Based Decision Making

Risk Prioritization: Identify and prioritize risks based on their severity and probability of occurrence. This helps allocate resources effectively and focus on the most critical risks first.
Risk Mitigation Strategies: Implement robust risk control measures to eliminate or minimize risks, such as design changes, safety features, and user training.
Corrective Action & Preventive Action (CAPA) Process: QMSR requires manufacturers to implement a robust corrective and preventive action (CAPA) process. This process is essential for addressing nonconformities and implementing corrective actions to prevent recurrence. It also includes taking preventive actions to address potential risks before they occur. By implementing an effective CAPA process, manufacturers can identify and mitigate risks in a timely manner, ensuring the ongoing safety and quality of their devices.

[/fusion_text][fusion_imageframe image_id=”20576|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Documentation and Transparency for Risk Management – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/07/Documentation-and-Transparency-for-Risk-Management-Celegence.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=”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=””]Documentation and Transparency[/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=””]

Maintenance of Comprehensive Risk Management Documentation: Document all risk management activities, including hazard identification, risk analysis, risk control, and risk evaluation. This documentation should be readily available for internal audits and FDA inspections.
Post-Market Surveillance and Monitoring: QMSR also emphasizes the importance of post-market surveillance and monitoring. Manufacturers are required to establish procedures for monitoring and analysing post-market information, including complaints, adverse events, and other feedback from users. This information is crucial for identifying potential risks and taking appropriate actions to mitigate them.

[/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=””]Key ISO 14971:2019 Takeaways for Manufacturers[/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=””]1. Emphasizing Risk Management: The QMSR recognizes the significance of risk management in ensuring the safety and effectiveness of medical devices. By incorporating risk management principles into the design, manufacturing, and post-market surveillance processes, manufacturers can proactively identify and mitigate potential risks. This leads to the development and availability of high-quality devices that meet regulatory requirements and provide optimal patient outcomes.

2. Adhering to Standards for Enhanced Safety: It is important to note that the QMSR is just one aspect of risk management in the medical device industry. Manufacturers should also consider other relevant standards and guidelines, such as ISO 14971, which provides a comprehensive framework for risk management in medical devices. By adhering to these standards and continuously improving their risk management processes, manufacturers can enhance patient safety and contribute to the overall advancement of the medical device industry.

3. Proactive Transition to QMSR: Manufacturers with existing products in the US market should proactively prepare for the transition from QSR to QMSR. This includes conducting thorough gap analysis, implementing transition plans with robust timelines, training resources, and conducting mock audits.[/fusion_text][fusion_imageframe image_id=”20577|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Expert in QMS Transition – 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=”left” caption_title=”” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” 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/2024/07/Expert-in-QMS-Transition-Celegence.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=”” 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 Expertise in QMS Transition[/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 assists medical device and IVD manufacturers in developing or altering their QMS in line with ISO 13485. Our services include thorough:

A thorough gap analysis
Remediation of the identified gaps through transition plans with robust timelines
Train the resources
Conduct mock audits

Celegence supports manufacturers to seamlessly manage their entire QMS transition or implementation process, guaranteeing compliance with regulatory deadlines. This advanced system streamlines regulatory navigation, enabling manufacturers to operate with greater efficiency and effectiveness.

To find out more about how we can help you with your QMS then reach out to us at info@celegence.com or contact us online for more information.

References

Medical Devices; Quality System Regulation Amendments
ISO 13485:2016 – Medical devices Quality management systems – Requirements for regulatory purposes
ISO 14971:2019 Medical devices – Application of risk management to medical devices

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animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”false”][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=”20px” 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=””]This blog was authored by Prasad Ravichandran, a Team Lead in Medical Device Regulatory Affairs at Celegence. Prasad is a Certified Lead Auditor for ISO 13485:2016, with extensive experience in medical devices and IVD technical documentation submission, CDSCO registration, and securing wholesale and import licenses. He is also an experienced clinical research auditor.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

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