A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufacturers?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Medical Device Presidents and CEOs
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
This webinar is being lead by Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc. Keith is a medical device regulatory affairs and quality system expert (Europse, Canada, USA) with 15+ years in the medical device industry.
This webinar is being moderated by Jon Speer, founder and VP of QA/RA at greenlight.guru. Jon is a medical device industry veteran with over 18+ years experience, has helped bring over 40 products to market in his career and is an expert at medical device quality system implementations.
Qserve Group is a global leading medical device consultancy group with all consultants formerly holding positions at medical device manufactures, European Notified Bodies, US FDA or Chinese CFDA. Their mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements, to guide manufacturers in gaining and maintaining official market access for their safe and qualitative medical devices without making regulatory more complicated than it already is.