# 130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-04-03
- Length: 32m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/130---QMSR-Changes-to-TraceabilityReporting--Independent-Reviewer--Risk-Management--Learning-New-Regulations-and-MDSAP-with-Aaron-Snyder-e2hsgqu

## Summary

Aaron Snyder, VP of Quality Assurance at Allotex and AAMI Faculty member, explains the FDA's Quality Management System Regulation (QMSR) and its incorporation of ISO 13485. He details specific changes to traceability, including the requirement to meet 21 CFR Part 821 (Medical Device Tracking) and Part 830 (UDI) in addition to ISO requirements, and new FDA-specific controls for records, packaging, and labeling. Snyder contrasts FDA inspection techniques, which focus on finding non-compliance through deep dives into complaint and service records, with ISO surveillance audits that verify conformity. He also discusses the impact of QMSR on MDSAP companies, noting that while harmonization simplifies compliance for large firms, smaller US-only companies face more work to adopt the process approach and explicit risk management.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=0) Introduction: Aaron Snyder and Allotex
- [2:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=149) QMSR Traceability: ISO 13485, Part 821, and UDI
- [5:34](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=334) Proposed vs. Final Rule: Packaging, Labeling, and Records
- [17:48](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=1068) FDA Inspection Techniques vs. ISO Surveillance Audits
- [23:50](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=1430) QMSR Impact on MDSAP and Small Companies
- [28:27](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management#t=1707) Learning New Regulations and the Independent Reviewer

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- Allotex (company)
- Fresenius Kabi (company)
- Molnlycke (company)
- Waters Corporation (company)
- Covidien (company)
- Cardinal Health (company)
- General Electric (company)
- AAMI (other)
- Quality Systems Explained (other)
- ISO 13485 (other)
- 21 CFR Part 821 (other)
- 21 CFR Part 830 (other)
- UDI (other)
- MDSAP (other)
- Good to Great (other)
- First Break All the Rules (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)
- [#431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte) (Global Medical Device Podcast)

## Citing this page

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