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iec62304-lifecycle-manager

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Medical device software lifecycle management skill implementing IEC 62304 requirements

library/specializations/domains/science/biomedical-engineering/skills/iec62304-lifecycle-manager/SKILL.md

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# IEC 62304 Lifecycle Manager Skill

## Purpose

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).

## Capabilities

- Software safety classification (Class A, B, C)
- Software development plan template generation
- SOUP (Software of Unknown Provenance) management
- Software architecture documentation templates
- Anomaly and problem tracking
- Configuration management guidance
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