Creating Performance Evaluation Plans and Reports under the IVDR
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Performance Evaluation Plans (PEPs) and Reports (PERs) are now required under the IVDR. Most companies have never performed PERs, which are perhaps the most complicated step to achieving IVDR compliance. Join R&Q's knowledgeable IVDR experts in a panel discussion of strategies and best practices for developing PEP's and PERs. We'll kick off the discussion with questions we've received on the following topics:
- Creating processes and templates for PERs and training your team on how to conduct them,
- Grouping products within PERs,
- Gathering and presenting data for the state of the art and other reports within the PER,
- Conducting lit searches, and
- Determining what is considered sufficient clinical evidence to satisfy the notified body.
We encourage you to bring your own questions for our experts to answer in real time. Don't miss this opportunity!
Here's the panel:
Ibim Tariah, Ph.D. — VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
Jon Gimbel, Ph.D. — Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
Ron Sills — Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
Eila Pattee — Senior Regulatory Scientist