IEC 62304 Medical Device Software Life Cycle Processes Auditor
Audits medical device software life cycle processes, development planning, risk analysis, and software safety classification.
Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.
How it works
Standard: IEC 62304 / ISO 13485 Medical Device Software Life Cycle Processes
Formula: Verify Software Safety Class (Class A, B, or C) and verification/validation protocol completion
Checks: Valid Software Safety Class (A-C)
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Deterministic local-first client-side execution. Provided as-is without warranty.