What Medical Device Software Validation & Lifecycle Processes - IEC 62304 (2026) requires
IEC 62304 specifies lifecycle requirements for the development of medical software and software within medical devices. It mandates a risk-based software safety classification (Class A, B, C) which determines the required rigor for software architecture, detailed design, unit verification, integration testing, and system testing.
Pillar: Medical & Healthcare · Authority: International Electrotechnical Commission (IEC) & ISO · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/64686.html
SHA-256 integrity: e9293caace3c4c0686d943fc4e7ed5094b19755da545ec2765348c37a240dbeb
Primary Citations — 1 traced to source
- IEC 62304:2006/AMD 1:2015 Medical device software - Software life cycle processes
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