iec62304-lifecycle-manager

# 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) ...