meddev-software-requirements
Guide creation, verification, and maintenance of software system requirements derived from system needs (IEC 62304:2006+A1:2015, 5.2)—with content appropriate to the device, risk controls embedded for Class B/C, and evidence that requirements are testable and traceable. Use when working on software requirements in medical device software.
- Version
- 1.0.0
- License
- MIT
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