# 198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-07-23
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/198---QMSR-Explained--ISO-13485-Compared--and-5-Key-Things-You-Mightve-Missed-e35svqn

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, breaks down five critical aspects of the FDA's new Quality Management System Regulation (QMSR). He explains that while QMSR harmonizes with ISO 13485, it retains 21 CFR 820 with FDA-specific overlays like UDI and complaint handling, and removes previous exemptions for certain manufacturers. Saadeh emphasizes that risk management remains mandatory despite not being explicitly named in the text, and warns that companies must complete gap assessments and training before the February 2, 2026 compliance deadline.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed#t=0) Introduction and Historical Context of QSR and ISO 13485

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

established companies

## Mentioned

- FDA (other)
- ISO 13485 (other)
- 21 CFR 820 (other)
- ISO 14971 (other)
- ICH Q9 (other)

## Related episodes from other shows

- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)
- [Meet a Guru: Sara Adams](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams) (Global Medical Device Podcast)

## Citing this page

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