a5c-ai 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