# #352: Fundamentals of Quality & Regulatory

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-01-18
- Length: 50m
- Episode: 352
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory
- Listen: https://podcast.greenlight.guru/episode/352-fundamentals-of-quality-regulatory

## Summary

Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

## Outline

1. Introduction: Jennifer Mascioli-Tudor and JMT Compliance Consulting
2. Origin Story: From Clinical Pharmacy to MedTech Quality
3. Proactive Quality: Influencing Business Leaders with Data
4. Human Factors and FDA Regulatory Trends
5. Building Culture and Growth Mindset in Quality Teams
6. Design Freeze and Agility in Software vs. Hardware
7. Essential Soft Skills: Project Management and Situational Leadership

## Topics

- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

companies scaling up, large enterprises

## Mentioned

- JMT Compliance Consulting (company)
- Medtronic (company)
- Boston Scientific (company)
- Johnson & Johnson (company)
- Greenlight Guru (company)
- UC San Diego extension (company)
- FDA (company)
- GE healthcare (company)
- Nevro (company)
- American medical Systems (company)
- outset medical (company)
- Genzyme (company)
- Eastern Michigan University (company)
- University of Phoenix (company)
- Enneagram (tool)
- DISC (tool)
- Myers Brigg (tool)

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- [014C - "The Final P: People" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager) (Let's Combinate)
- [247 - Why Everyone in Pharma and MedTech Should Work in Quality](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-22-247-why-everyone-in-pharma-and-medtech-should-work-in-quality) (Let's Combinate)
- [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)
- [179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing) (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)

## 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/2024-01-18-352-fundamentals-of-quality-regulatory. 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.