# QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-03-16
- Length: 48m
- Episode: 250
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices
- Listen: https://podcast.greenlight.guru/episode/qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices

## Summary

Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting discuss the FDA's proposed Quality Management System Regulation (QMSR) to align 21 CFR Part 820 with ISO 13485:2016. The panel argues that the transition is a small leap for compliant companies, focusing on paperwork rather than engineering changes, and questions the value of constant regulatory updates. They highlight the tension between compliance and actual product quality, noting that while harmonization is a step toward global standards, true global regulatory harmonization remains unlikely due to differing national protections.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=0) Introduction: Mike Drues and George Zack on FDA QMSR Proposal
- [4:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=246) FDA's Piecemeal Approach to ISO 13485 Adoption
- [7:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=466) Global Harmonization and Substantial Similarity
- [11:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=661) Timeless Regulation vs. Frequent Updates
- [15:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=910) Compliance vs. Quality and the 'Boneheaded' Mistakes
- [20:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=1216) Transition Timeline and Resource Constraints
- [25:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=1542) Paperwork Changes and Procrastination
- [30:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=1855) Small Companies and Standards Participation
- [35:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=2127) MDSAP, Certifications, and Inspection Inconsistencies
- [40:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices#t=2428) ISO 13485 as a Sanity Check for US-Only Companies

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Two Harbors Consulting (company)
- ISO 13485:2016 (other)
- 21 CFR Part 820 (other)
- EU MDR (other)
- MDSAP (other)
- Greenlight Guru (company)

## Related episodes from other shows

- [125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh) (Let's Combinate)
- [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)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (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)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)

## Citing this page

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