meddev-iec-62304-software-risk
Guide implementation of the software-specific risk management process (IEC 62304:2006+A1:2015, Clause 7) alongside ISO 14971:2019—identifying how software items contribute to hazardous situations, defining and verifying software risk controls, and re-analysing risk when software changes. Use when working on iec 62304 software risk in medical device software.
- Version
- 1.0.0
- License
- MIT
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