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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-09-26
- Length: 44m
- Episode: 384
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech
- Listen: https://podcast.greenlight.guru/episode/384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech-trends

## Summary

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.

## Outline

1. Introduction: Vincent Cafiso and Creo Consulting
2. Bridging R&D and Production: Aligning Testing Environments
3. Top Trends in Quality Systems: Documentation Gaps and Standards
4. Management’s Role in Enforcing Quality Controls
5. From FDA Investigator to Industry: Regulatory Mindset
6. Skip-Level Meetings and Breaking Silos in Large Organizations
7. Final Takeaways: Building a Culture of Quality

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

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

## Mentioned

- Creo Consulting (company)
- Greenlight Guru (company)
- FDA (other)
- IVDR (other)
- PMA (other)

## Related episodes from other shows

- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.