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Agent skill
iec62304-lifecycle-manager
Medical device software lifecycle management skill implementing IEC 62304 requirements
Install this agent skill to your Project
npx add-skill https://github.com/a5c-ai/babysitter/tree/main/library/specializations/domains/science/biomedical-engineering/skills/iec62304-lifecycle-manager
Metadata
Additional technical details for this skill
- domain
- science
- category
- Medical Device Software
- skill id
- BME-SK-019
- specialization
- biomedical-engineering
SKILL.md
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 control
- Plan maintenance activities from project start
Process Integration
This skill integrates with the following processes:
- Software Development Lifecycle (IEC 62304)
- Software Verification and Validation
- AI/ML Medical Device Development
- Medical Device Risk Management (ISO 14971)
Dependencies
- IEC 62304 standard
- AAMI TIR45 guidance
- Configuration management tools
- Issue tracking systems
- Development environments
Configuration
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
Output Artifacts
- Software development plans
- Safety classification rationale
- SOUP management documentation
- Architecture documents
- Requirements specifications
- Anomaly management reports
- Configuration management plans
- Maintenance plans
Quality Criteria
- Safety classification justified by hazard analysis
- Documentation appropriate for safety class
- SOUP properly evaluated and controlled
- Configuration management comprehensive
- Anomaly management effective
- Maintenance activities planned
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