Live! #16 — Creating Performance Evaluation Plans and Reports under the IVDR

40:02
 
Share
 

Manage episode 270888151 series 2688337
By RQM+. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

This is the audio-only version of DEVICE LOVE Live! #16, originally recorded August 27, 2020.

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
  • 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

Moderator:

  • Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

The and means more.

--- Send in a voice message: https://anchor.fm/deviceadvice/message

43 episodes