Maintaining Clinical Evaluation Reports (CERs) has become one of the most resource-intensive challenges for medical device manufacturers operating under EU MDR. As portfolios expand and renewal cycles tighten, manufacturers are expected to demonstrate continuous clinical evidence maintenance – not just periodic CER updates.

Manual CER maintenance, including literature surveillance, document comparisons, and portfolio alignment, places significant operational strain on regulatory and clinical teams. These repetitive activities consume valuable expert time and increase the risk of inconsistencies across CER versions.

This webinar demonstrates how AI-driven automation enables a more efficient and sustainable CER maintenance approach. You’ll see how CAPTIS®, Celegence’s AI-powered regulatory compliance platform, supports :

• Automated literature surveillance and evidence identification
• Structured comparisons across CER versions
• Portfolio-wide consistency and traceability
• Faster, more reliable CER maintenance aligned with EU MDR expectations

This approach allows manufacturers to reduce operational burden while improving regulatory confidence and long-term compliance readiness.

In this on-demand webinar, Celegence experts demonstrate how AI-enabled automation helps regulatory and clinical teams improve efficiency, strengthen documentation consistency, and support audit readiness across device portfolios.

 

Watch Now: Beyond the Spreadsheet: The Silent Cost of Data Chaos in Regulatory Affairs

Regulatory teams in the pharmaceutical industry face mounting pressure to manage increasingly complex datasets while staying compliant with evolving global requirements. Yet many organizations still rely on outdated tools like spreadsheets and siloed systems – creating inefficiencies, compliance risks, and escalating costs.

In this on-demand webinar, our expert examines the hidden costs of regulatory data chaos and outlines practical solutions to modernize processes. Learn how technology-enabled approaches can transform data management, reduce compliance costs, and enable regulatory affairs teams to focus on strategy rather than firefighting.

 

Why Watch

If your team is still struggling with fragmented data, manual tracking, and rising compliance costs, this session will help you identify opportunities for efficiency and long-term cost reduction. Move beyond the spreadsheet and take the first step toward scalable, future-ready regulatory operations.

Watch the webinar recording now and learn how to reduce compliance costs while regaining control of your regulatory data.

With the transition from MDD to MDR, dental device manufacturers are facing increased scrutiny around clinical evidence, documentation gaps, and evaluation methodology. Aligning with EU MDR requirements can be especially challenging given the wide variety of dental products and risk classifications.

In this expert-led on-demand webinar, our speakers provide targeted guidance on building MDR-compliant Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and supporting documentation tailored to dental devices.
If you’re looking to improve your clinical evaluation strategy and minimize the risk of delays or rejections by Notified Bodies – this session is for you.

 

Watch Now: Staying Compliant: Strategies for EU MDR and Beyond

Staying compliant with the EU Medical Device Regulation (MDR) is no longer just a checkbox exercise. As regulatory demands grow in complexity, medical device manufacturers must rethink their approach to compliance—prioritizing strategy, accuracy, and adaptability.

In this on-demand webinar, regulatory experts from Celegence provide a deep dive into the most pressing MDR challenges and how leading organizations are leveraging tools, processes, and expert insights to minimize risks and maintain certification with confidence.

Whether you’re preparing for your next audit or trying to streamline compliance processes, this webinar delivers relevant, real-world insights from experts who actively support global medical device firms.

AI and Automation for Regulatory Compliance in Medical Devices – Smarter Data Management

In today’s stringent regulatory environment, medical device and IVD manufacturers face mounting challenges to remain compliant while managing growing data complexities. Discover how AI and automation, including Celegence’s CAPTIS® platform, can streamline regulatory processes, improve data accuracy, and reduce compliance costs.

This on-demand webinar provides an in-depth overview of technology-driven solutions to help regulatory professionals modernize their compliance efforts. As regulatory demands evolve, smarter solutions like CAPTIS® are essential for managing compliance effectively.

The session demonstrates how AI-powered tools and automation technologies can simplify regulatory data management, optimize submission quality, and ensure compliance with EU MDR and IVDR requirements. By leveraging AI-driven solutions, regulatory teams can significantly ease their burden, improve efficiency, and drive precision in clinical and technical documentation processes.

With real-world insights and practical examples, this webinar equips you with actionable strategies to simplify regulatory affairs, enhance accuracy, and achieve cost-effective compliance management.

Don’t miss this opportunity to enhance your regulatory skills and understanding.

 

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Managing Global Regulatory Strategy and Compliance: Assessing Status, Gaps, and Needs

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Join us for an engaging discussion where industry leaders will share key insights and findings from a recent survey conducted with Medtech Intelligence. This webinar will explore the top challenges and opportunities in the medical device industry, discuss planned investments for the near and long term, and provide guidance on aligning with evolving regulatory requirements. Topics will include identifying regulatory gaps, risk mitigation strategies, and leveraging technology and resources to enhance compliance.

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Don’t miss this opportunity to enhance your regulatory skills and understanding.

 

Gain actionable knowledge and insights with our webinar:

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Identify Regulatory Gaps: Understand why gaps in regulatory intelligence and compliance processes are overwhelming for teams and organizations.

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Risk Mitigation: Learn strategies to mitigate risks associated with the growing complexities of global regulatory compliance.

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Focus Areas: Discover where to prioritize MDR/IVDR efforts and investments.

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Technology and Resources: Explore technologies and resources for cost-effective management of current bandwidth limitations in the industry.[/fusion_li_item][/fusion_checklist][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”Contact” type=”legacy” hundred_percent=”no” hundred_percent_height=”no” min_height_medium=”” min_height_small=”” min_height=”” hundred_percent_height_scroll=”no” align_content=”stretch” flex_align_items=”flex-start” flex_justify_content=”flex-start” flex_column_spacing=”” hundred_percent_height_center_content=”yes” equal_height_columns=”no” container_tag=”div” menu_anchor=”demoCTA” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” 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Are you seeking assistance with a regulatory compliance need?

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Please complete the form below to outline your medical device/pharmaceutical/IVD regulatory support requirements. Our team will promptly review your submission and reach out to confirm a consultation time. Thank you for your interest