# 125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-02-28
- Length: 42m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/125---Unpacking-the-Quality-Management-System-RegulationQMSR-Final-Rule-with-Subhi-Saadeh-e2gcgri

## Summary

Subhi Saadeh, host of the Combinate Podcast and Quality Professional, conducts an active reading of the FDA's Quality Management System Regulation (QMSR) Final Rule to unpack changes to 21 CFR 820 and 21 CFR 4. He details the harmonization of the Quality System Regulation (QSR) with ISO 13485, highlighting new sections like 820.10 and 820.45, and the reclassification of previous QSR subparts as 'reserved.' Saadeh also analyzes FDA comments regarding combination products, component manufacturers, and the practical implications of aligning US regulations with global standards to reduce industry inefficiency.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh#t=0) Introduction and Subhi Saadeh's Background

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

established companies

## Mentioned

- FDA (company)
- ISO 13485 (other)
- 21 CFR 820 (other)
- 21 CFR 4 (other)
- ASQ (company)

## Related episodes from other shows

- [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)
- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (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)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)

## Citing this page

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