Hardware Podcasts

How to Leverage IEC 62304 to Improve SaMD Development Processes

Global Medical Device Podcast · 18 Mar 2020 · 37m · Episode 137

What this episode covers

Cathy Wilburn, Director of Quality Assurance and Compliance at The RND Group, explains how to leverage the IEC 62304 standard for Software as a Medical Device (SaMD) development. She clarifies that IEC 62304 is a voluntary, recognized consensus standard that provides a framework for software lifecycle processes rather than a prescriptive waterfall methodology, allowing for agile integration. The discussion covers mapping these processes to FDA 21 CFR 820.30 design controls, using software safety classes (A, B, C) for risk management per ISO 14971, and navigating regulatory submissions for both the US (510(k)/PMA) and EU (MDR/IVDR).

Most relevant to

early-stage companies

Topics

Mentioned

Companies
The RND Group, Green Light Guru
Also
IEC 62304, FDA, ISO 14971, EU MDR, TIR 45

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