medical-device-software
This plugin enforces IEC 62304 and IEC 81001-5-1 compliance for medical device software through four deterministic Python scripts that classify software safety class, check lifecycle activities, verify SOUP/SBOM register consistency, and validate requirement traceability matrices. It requires no external services or APIs, running offline using only Python standard library to audit evidence and flag regulatory gaps for FDA and EU MDR submissions.
Install
Source: https://github.com/alirezarezvani/claude-skills/tree/HEAD/ra-qm-team/medical-device-software
What it's made of
2 commands · 1 agent · 1 skill
- Commands
- 2
- Agents
- 1
- Skills
- 1
- MCP servers
- 0
- Hooks
- 0
What it needs & plugs into
- API keys
- none
- Paid services
- none detected
- External tools
- none
- Talks to
- nothing external detected
Analyzed . Facts extracted from the plugin's files. Prose generated by claude-haiku-4-5-20251001.
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