Hardware Podcasts

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

Global Medical Device Podcast · 16 Mar 2022 · 48m · Episode 250

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Two Harbors Consulting, Greenlight Guru
Also
ISO 13485:2016, 21 CFR Part 820, EU MDR, MDSAP

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