iec62304-lifecycle-manager
Medical device software lifecycle management skill implementing IEC 62304 requirements
npx skills add a5c-ai/babysitter --skill iec62304-lifecycle-manager --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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 - Maintenance planning - Software requirements specification templates - Unit/integration test planning - Release documentation - Change control workflows ## Usage Guidelines ### When to Use - Planning medical device software projects - Classifying software safety levels - Managing SOUP components - Preparing for regulatory submissions ### Prerequisites - Device intended use defined - Software scope identified - Hazard analysis completed - Development team resources available ### Best Practices - Classify software based on hazard analysis - Document all SOUP with risk assessments - Maintain comprehensive change contro
- Purpose
- Capabilities
- Usage Guidelines
- When to Use
- Prerequisites
- Best Practices
- Process Integration
- Dependencies
- Configuration
- Output Artifacts
- Quality Criteria
What does the iec62304-lifecycle-manager skill do?
Medical device software lifecycle management skill implementing IEC 62304 requirements
How do I install it?
Run `npx skills add a5c-ai/babysitter --skill iec62304-lifecycle-manager --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From a5c-ai/babysitter, a repository with 1,642 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.