What IEC 62304 - Medical Device Software Lifecycle Processes (2026) requires
The globally recognized foundational standard defining the lifecycle processes required for developing medical device software. It mandates a rigorous, risk-based approach to software architecture, detailed requirement tracing, and verification, scaling the documentation burden based on the software's Safety Class (A, B, or C).
Pillar: Medical & Healthcare · Authority: International Electrotechnical Commission (IEC) & ISO · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/38421.html
SHA-256 integrity: 523ee643394ceb79f10e43cb338f7ab99059bc88f6395fb7488adae53a7c4ca3
Primary Citations — 1 traced to source
- IEC 62304:2006+AMD1:2015 Medical device software - Software life cycle processes
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