October 23, 2020

Live! #21 — Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys

40 minutes

This is the audio-only version of DEVICE LOVE Live! #21, originally recorded 22 October 2020.

Will collecting the data be successful?

One of the biggest challenges to EU MDR compliance is meeting the requirements of Post-Market Clinical Follow-up. Many device companies are hoping the combination of literature reviews and PMCF surveys will be “enough” because those approaches are much less resource intensive than registry studies and clinical investigations.

In this show our experts will discuss:

Circumstances when PMCF surveys are an appropriate PMCF activity

Documenting justification for the survey activity in the PMCF Plan

(especially as compared to other activities)

Survey feedback from notified bodies; common pitfalls and how to avoid them

Best practices to increasing your odds of a successful notified body review of your survey data and report

If you’re anxious to kick off your survey program but have some concerns, please join us and bring your questions!

Here's the panel:

Ibim Tariah, Ph.D. – VP of EU MDR and IVDR Consulting Services, R&Q (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)

Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)

Torrie DeGennaro – Associate Engineer, R&Q

Celeste Maksim, Ph.D. – Principal Consultant, R&Q

Brian Hockett – Project Engineer, R&Q

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.

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