Medical & Healthcare

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, IEC 81001-5-1 security, or the FDA documentation level and 524B cyber-device duties. Checks the user's files with four scripts that cite the clause.

Publisher / source

Claude Skills Collection

Upstream record

alirezarezvani/claude-skills

Version

Version 1

Published

2026-11-12

Publication review

Approved for publication

Content fingerprint

32760d4f4261acc0857aadcd11ee70064ffcde05c0a3b75fffe1536519773001