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#438: QMSR Mythbusters Episode

Global Medical Device Podcast powered by greenlight.guru by Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

Dec 22, 202519:07Business

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in...

About This Episode

#438: QMSR Mythbusters Episode is an episode from Global Medical Device Podcast powered by greenlight.guru by Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory. The FDA...

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Episode Details

Published Dec 22, 2025, 19:07 long, audio available.