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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-03-20
- Length: 52m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/128---Former-FDA-Inspector-and-Managing-Consultant--Vin-Cafiso-CadaversAutopsies--Tales-from-FDA-Inspections--Understanding-the-QMSR--and-Quality-Culture-e2h9pr6

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=0) Introduction: Vin Cafiso and Practical Compliance Results
- [1:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=95) Vin's Journey: From Pre-Med Autopsies to FDA Investigator
- [6:09](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=369) QMSR Impact: Terminology Changes and Small Company Challenges
- [15:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=900) FDA Inspection Methodology: From 483s to QSET Process Audits
- [27:45](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=1665) Assessing Quality Culture: The 'Sniff Test' and Management Engagement
- [44:18](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t#t=2658) Career Transition: Why Starting at FDA Builds Industry Success

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

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

## Mentioned

- Practical Compliance Results (company)
- FDA (other)
- QMSR (other)
- QSR (other)
- ISO 13485 (other)
- BD (company)
- Smith & Nephew (company)
- BioArray Solutions (company)
- Impulse Dynamics (company)

## Related episodes from other shows

- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)
- [Meet a Guru: Sara Adams](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)

## Citing this page

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