claude

medical-device-software

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.

29,725 on GitHubby Alireza Rezvaniv2.14.11MITupdated yesterdaycompliance
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Plugin medical-device-software from marketplace claude-code-skills in alirezarezvani/claude-skills. Commands read from the repo's manifest — today.

What it installs

Skills (1)

  • medical-device-software

    Use for any question about the software inside a medical device, SaMD or regulated health app - which IEC 62304 safety class (A/B/C) it is and how much process and documentation that class needs, what to record about open-source or third-party libraries (SOUP, SBOM), trace matrix and release testing

Slash commands (2)

  • /medical-device-software:cs-medical-device-software

    Full IEC 62304 / IEC 81001-5-1 pass on medical device software - classify, check lifecycle activities for the class, check SOUP and SBOM, gate the trace matrix for release.

  • /medical-device-software:cs-soup-review

    Review a medical device SOUP register against IEC 62304 (8.1.2, 5.3.3, 5.3.4, 7.1.3) and IEC 81001-5-1, and cross-check it with the SBOM for FD&C Act 524B.

Subagents (1)

  • cs-device-software-lead

    Use when medical device or SaMD software needs its IEC 62304 safety class, a lifecycle gap check, a SOUP list or SBOM reviewed, a trace matrix checked before release, IEC 81001-5-1 security activities scoped, or the FDA Basic/Enhanced documentation level and 524B cyber-device duties decided. Runs fo

View source on GitHub alirezarezvani.medium.com

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