# #440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-01-05
- Length: 50m
- Episode: 440
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory
- Listen: https://podcast.greenlight.guru/episode/440-icymi-episode-fundamentals-of-quality-regulatory

## Summary

Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory#t=0) Introduction and Origin Story
- [6:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory#t=411) Quality as an Enabler and Influencer
- [16:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory#t=971) Human Factors and End-User Feedback
- [21:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory#t=1291) Project Management and Soft Skills
- [24:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory#t=1453) Design Freeze and Regulatory Agility

## Topics

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

## Most relevant to

established companies

## Mentioned

- JMT Compliance Consulting (company)
- Medtronic (company)
- Boston Scientific (company)
- Greenlight Guru (company)
- UC San Diego Extension (company)
- FDA (company)
- Steve Jobs (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)
- [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)
- [066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-04-066-scientist-to-cso-learning-qa-ra-marketing-and-saying-yes-to-oppurtunities-wi) (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)
- [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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