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FREE On-demand webinar

Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

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The European In Vitro Diagnostic Medical Device Regulation (IVDR) will go into effect in May 2022 and have profound impacts on the world’s second-largest medical device market.

IVDR introduces major changes to how manufacturers can obtain CE Marking and maintain access to the European market.

About 80% of companies have yet to make the transition to IVDR. Preparing for compliance with these new, more robust requirements presents significant challenges to manufacturers needing to  organize their regulatory transition strategies to achieve critical success factors, such as:

  • Technical Documentation of their devices, now for the first time ever, subject to Notified Body scrutiny
  • New, more detailed requirements on IVD performance evaluation documentation, including:
    • Performance Evaluation Plan (PEP)
    • Performance Evaluation Report (PER)
    • Supporting documentation on scientific validity, analytical performance, and clinical performance
  • Robust requirements in relation to Post-Market Surveillance (PMS), including Post-Market Performance Follow-up (PMPF)

We've teamed up with EMERGO by UL to share their expertise on IVDR and provenly effective ways for IVD manufacturers to make a smooth transition in meeting all compliance requirements.

 

Specifically this webinar will cover: 

  • Key aspects about what manufacturers can expect from these new regulations
  • How to prepare Technical Documentation
  • Best practices for IVDR compliance and Notified Body review
  • Proven tools and resources proven to streamline transition to IVDR
  • Q&A Session

Who should attend?

  • In Vitro Diagnostic Device Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • R&D Engineers and Management

  • Clinical Affairs Professionals and Management

 

Presenters

Michael-Dun

Michael Dun
Senior Consultant
EMERGO by UL

Moderator

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Jon Speer
Founder & VP of QA/RA
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. Visit our homepage to learn more.

 

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ABOUT Emergo by UL

EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow. Visit our website to learn more.

 

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