Hardware Podcasts

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

Let's Combinate · 23 Jul 2025 · 10m

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, breaks down five critical aspects of the FDA's new Quality Management System Regulation (QMSR). He explains that while QMSR harmonizes with ISO 13485, it retains 21 CFR 820 with FDA-specific overlays like UDI and complaint handling, and removes previous exemptions for certain manufacturers. Saadeh emphasizes that risk management remains mandatory despite not being explicitly named in the text, and warns that companies must complete gap assessments and training before the February 2, 2026 compliance deadline.

Most relevant to

established companies

Topics

Mentioned

Also
FDA, ISO 13485, 21 CFR 820, ISO 14971, ICH Q9

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