Hardware Podcasts

#438: QMSR Mythbusters Episode

Global Medical Device Podcast · 22 Dec 2025 · 19m · Episode 438

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA, Greenlight Guru
Also
ISO 13485:2016, 21 CFR Part 820, MDSAP, UDI

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The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.