Episode Details

This is the audio-only version of DEVICE LOVE Live! #19, originally recorded 24 September, 2020.

There's a lot of uncertainty in the industry around meeting the requirements of Post-Market Clinical Follow Up (PMCF) under the EU MDR and Post-Market Performance Follow Up (PMPF) under the IVDR.

Will what I have be enough or am I planning for too much? How do I get the functions aligned... PMS, Regulatory, Risk, Clinical, Marketing?

It's not easy!

In this show we'll answer popular questions from our clients and as well as live audience questions. So please, bring your challenges to the table: we'll be ready!

Here's the panel:

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) Celeste Maksim, Ph.D. – Principal Consultant Niki Caporali-Spaniel, RAC – Principal Specialist Brian Hockett – Project Engineer


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.

We are passionate about your success. Tell us more about your needs so we can help.

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