Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys
DEVICE L❤️VE Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. The panelists also answer audience questions. Every episode is added to our podcast, too.
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 Clinicalat BSI)
Torrie DeGennaro – Associate Engineer, R&Q
Celeste Maksim, Ph.D. – Principal Consultant, R&Q
Brian Hockett – Project Engineer, R&Q