Live! #3 — Recent MDD and MDR Audit Findings: What are we seeing?

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This is the audio-only version of DEVICE LOVE Live! #3, originally recorded May 1st, 2020.

Notified Body auditors have increased scrutiny as promised in both initial Medical Device Regulation (MDR) certification audits and routine Medical Device Directive (MDD) audits. Novel major findings are being issued on long standing processes and legacy products. In this panel discussion, R&Q experts will talk about what we are seeing across the medical device industry. Our experts will provide recommendations on where to focus your resources to increase the odds of passing a notified body audit without major findings.

Panelists:

  • Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI)
  • Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q
  • Jon Gimbel, Ph.D. — Executive Directory of Regulatory and Quality Consulting Services, R&Q
  • Ron Sills — Senior Principal Specialist, R&Q (former TÜV Rheinland)

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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43 episodes