Hardware Podcasts

128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

Let's Combinate · 20 Mar 2024 · 52m

What this episode covers

Vin Cafiso, former FDA Consumer Safety Officer and Managing Consultant at Practical Compliance Results, discusses the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and its impact on small medical device companies. He explains how FDA inspection methodologies are shifting from issue-focused 483s to process-based QSET audits, emphasizing the importance of understanding quality culture through simple engagement rather than rigid metrics. Cafiso shares insights from his career at companies like BD and Smith & Nephew, highlighting how starting as an investigator builds a strong foundation for industry roles by providing a broad view of quality systems across diverse products and company sizes.

Most relevant to

early-stage companies, companies scaling up, established companies and large enterprises

Topics

Mentioned

Companies
Practical Compliance Results, BD, Smith & Nephew, BioArray Solutions, Impulse Dynamics
Also
FDA, QMSR, QSR, ISO 13485

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