# #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-08-15
- Length: 36m
- Episode: 379
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-15-379-meet-the-guru-building-quality-management-in-early-stage-medical-device-comp
- Listen: https://podcast.greenlight.guru/episode/379-meet-the-guru-navigating-quality-management-in-early-stage-medical-device-companies-and-other-insights-from-a-veteran-engineer

## Summary

Vernon Baker, a veteran medical device engineer and quality expert, explains how early-stage MedTech companies can build effective Quality Management Systems (QMS) without massive resources. He emphasizes that early quality hires must be 'jack of all trades' who understand core regulations like ISO 13485 and 21 CFR 820, but prioritize humility and the ability to find answers over being an expert in everything. Key strategies include rigorous supplier management, treating suppliers as extensions of the manufacturing process, and conducting real, risk-based management reviews rather than checkbox exercises. Baker also highlights the importance of establishing a formal regulatory intelligence process to track standards like ISO 14971 and EU MDR, ensuring compliance drives product development and business survival.

## Outline

1. Introduction: Vernon Baker's Background from Naval Nuclear to MedTech
2. Wearing Many Hats: The 'Jack of All Trades' Early Quality Hire
3. Supplier Management: Audits, Quality Agreements, and Risk
4. Management Reviews: Moving Beyond Checkbox Compliance
5. Regulatory Intelligence: Tracking Standards and Gap Analysis
6. Final Advice: Hiring for Humility, Boldness, and Passion

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Rook Quality System (company)
- ISO 13485 (other)
- ISO 14971 (other)
- 21 CFR 820 (other)
- EU MDR (other)
- TUV Sud (other)
- BSI (other)
- Oriel Stata Matrix (other)

## Related episodes from other shows

- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [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)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (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)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (Let's Combinate)

## Citing this page

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