Live! #6 — PMCF Process in Action: Best Practices for MDR Compliance

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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! #6, originally recorded May 21st, 2020.

Join us for an open discussion with former FDA and Notified body representatives.

— What's it like moving from government to industry? — What do they miss about their previous roles? — Why do they prefer being in industry…or do they? — What do they wish both sides knew about the other? — What are key takeaways to successfully navigate the system?

Panelists:

  • Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
  • Jon Gimbel, Ph.D. — Executive Director of Regulatory and Quality Consulting Services, R&Q
  • Celeste Maksim, Ph.D., RAC — Principal Specialist
  • Johnna Dominick — Project Controller

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