IEC 62304 (Medical device software – Software life cycle processes) is the harmonized international standard defining structured engineering, risk management, and maintenance processes for medical software—covering both embedded software (SiMD) and standalone Software as a Medical Device (SaMD).
Why IEC 62304 Compliance Matters
- Regulatory Market Access: Both EU Notified Bodies (under MDR/IVDR) and the US FDA expect medical software lifecycle documentation aligned with IEC 62304.
- Patient Safety (Classes A, B & C): Software safety classification scales engineering rigor and verification depth proportionally to potential patient harm.
- Structured Quality & SOUP Control: Covers software requirements, architectural design, third-party libraries (SOUP), unit/integration/system testing, and configuration management.
- Traceable Maintenance: Ensures safe, controlled updates, bug fixes, and change management throughout the software's commercial lifecycle.
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