meddev-iso-14971
Integrate ISO 14971:2019 device risk management into software development: hazard identification, risk evaluation, control implementation, verification, and residual risk documentation. For IEC 62304 Clause 7 software-specific risk activities, also load REG-IEC62304-SWRM. Use when working on iso 14971 in medical device software.
- Version
- 1.1.0
- License
- MIT
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