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

Originally recorded Friday, May 1st

Notified Body (NB) 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 NB audit without major findings.

This outstanding panel will include:

• Ibim Tariah, R&Q VP of EU MDR/IVDR Consulting Services; former BSI Technical Director of Medical Devices through 2019
• Ron Sills, R&Q Sr. Principal Specialist; former TUV Rhineland Lead Auditor through 2019
• Nancy Morrison, R&Q Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Counsel
• Jon Gimbel, R&Q Exec. Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER business