Hardware Podcasts

#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

Global Medical Device Podcast · 26 Sept 2024 · 44m · Episode 384

What this episode covers

Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator, discusses the critical need for MedTech companies to align R&D testing environments with production standards to avoid costly rework and data rejection. He highlights common pitfalls in design controls, such as missing real-time aging data and inadequate documentation in Design History Files, urging companies to integrate quality validation early in the development process. Cafiso also emphasizes the importance of management responsibility and breaking down organizational silos through skip-level meetings to maintain a collaborative, startup-like culture as companies scale from garage startups to enterprise levels.

Most relevant to

founders before launch, early-stage companies, companies scaling up and large enterprises

Topics

Mentioned

Companies
Creo Consulting, Greenlight Guru
Also
FDA, IVDR, PMA

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The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.