Hardware Podcasts

125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

Let's Combinate · 28 Feb 2024 · 42m

What this episode covers

Subhi Saadeh, host of the Combinate Podcast and Quality Professional, conducts an active reading of the FDA's Quality Management System Regulation (QMSR) Final Rule to unpack changes to 21 CFR 820 and 21 CFR 4. He details the harmonization of the Quality System Regulation (QSR) with ISO 13485, highlighting new sections like 820.10 and 820.45, and the reclassification of previous QSR subparts as 'reserved.' Saadeh also analyzes FDA comments regarding combination products, component manufacturers, and the practical implications of aligning US regulations with global standards to reduce industry inefficiency.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA, ASQ
Also
ISO 13485, 21 CFR 820, 21 CFR 4

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