Medical device software lifecycle management skill implementing IEC 62304 requirements
Manages medical device software lifecycle ensuring IEC 62304 compliance for classification, documentation, and maintenance.
npx claudepluginhub a5c-ai/babysitterThis skill is limited to using the following tools:
The IEC 62304 Lifecycle Manager Skill supports medical device software lifecycle management per IEC 62304, ensuring proper classification, documentation, and maintenance of software as a medical device (SaMD) and software in medical devices (SiMD).
This skill integrates with the following processes:
iec62304-lifecycle-manager:
safety-classes:
- Class-A
- Class-B
- Class-C
lifecycle-phases:
- planning
- requirements
- architecture
- detailed-design
- implementation
- verification
- release
- maintenance
document-types:
- development-plan
- requirements-spec
- architecture-doc
- test-plans
- release-notes
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