Medical & Healthcare
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
Version
Version 1
Published
2026-11-12
Publication review
Approved for publication
Content fingerprint
32760d4f4261acc0857aadcd11ee70064ffcde05c0a3b75fffe1536519773001
Review before you use it
Publication approval is a recorded review state, not a guarantee of safe execution. Check the upstream license, required tools and permissions, and test in your intended client.
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Source: https://prompeteer.ai/skills-hub/a9689bb7-9d0b-4fd0-a315-0fa8e7808399