Regulatory pathway · all topics

IEC 62304 Medical Device Software Lifecycle

IEC 62304:2006+A1:2015 defines lifecycle requirements for medical device software. Software safety classification A (no possible injury), B (non-serious injury possible), C (death or serious injury possible). Class C software requires unit testing, integration testing, and architectural design with software item segregation. Verification, validation, configuration management, and problem resolution processes are required for all classes. Cited by FDA as recognized consensus standard. Often paired with ISO 14971 for risk and IEC 82304-1 for health software product.

Source

IEC 62304:2006+A1:2015 'Medical device software - Software life cycle processes'

https://www.iso.org/standard/64686.html

How MedTek OS handles this

Compass drafts the iec 62304 medical device software lifecycle workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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