meddev-iec-62304-legacy-software
Guide use of the legacy software pathway (IEC 62304:2006+A1:2015, 4.4) when device software was legally marketed before full lifecycle evidence existed—balancing continued use with gap analysis, risk management, and targeted closure activities instead of re-running all of Clauses 5–9 from scratch. Use when working on iec 62304 legacy software in medical device software.
- Version
- 1.0.0
- License
- MIT
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