# #438: QMSR Mythbusters Episode

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-12-22
- Length: 19m
- Episode: 438
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode
- Listen: https://podcast.greenlight.guru/episode/438-us-medical-device-qmsr-the-core-quality-system-shakeup

## Summary

Host Etia Nichols from Greenlight Guru explains the FDA's new Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, with a mandatory enforcement date of February 2, 2026. Nichols debunks the myth that the Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR) are being eliminated, clarifying they are mapped to the Medical Device File (MDF), Design and Development File (DDP), and Batch or Lot Record respectively. She highlights three critical shifts: the explicit integration of lifecycle risk management as the 'DNA' of the QMS, the loss of audit privilege making internal records inspectable, and retained US-specific requirements like UDI in complaint records and extended record retention.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode#t=31) Introduction to QMSR and Harmonization

## Topics

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

## Most relevant to

established companies

## Mentioned

- FDA (company)
- ISO 13485:2016 (other)
- 21 CFR Part 820 (other)
- Greenlight Guru (company)
- MDSAP (other)
- UDI (other)

## Related episodes from other shows

- [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)
- [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)
- [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)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)

## Citing this page

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