medical-device-software

alirezarezvani/claude-skills

Get medical device software through IEC 62304 and IEC 81001-5-1. Four deterministic stdlib scripts: a software safety classifier (62304 4.3 with A1 external controls and segregation) that also sets the FDA Basic/Enhanced documentation level and flags 524B cyber devices; a lifecycle gap check scoped by class, with IEC 81001-5-1 security activities; a SOUP register check with SBOM cross-check; and a trace matrix release gate. Ships cs-device-software-lead agent, /cs-medical-device-software and /cs-soup-review commands and 4 references with per-claim confidence levels.

version

2.14.11

GitHub stars

29.6K

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