Hardware Podcasts

170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

Let's Combinate · 8 Jan 2025 · 9m

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains how viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles simplifies implementation for medical device and combination product companies. He contrasts the standard's framework approach with mandatory regulations like 21 CFR 820, demonstrating how each clause from QMS (Clause 4) to Design and Development maps to specific PDCA stages. Saadeh argues that this perspective shifts ISO 13485 from a static rule book to a dynamic guide for continuous improvement and real-world process effectiveness.

Most relevant to

early-stage companies

Topics

Mentioned

Also
ISO 13485, 21 CFR 820, MDSAP

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