name
iec62304-lifecycle-manager
description
Medical device software lifecycle management skill implementing IEC 62304 requirements
allowed-tools
["Read","Write","Glob","Grep","Edit","Bash"]
metadata
{"specialization":"biomedical-engineering","domain":"science","category":"Medical Device Software","skill-id":"BME-SK-019"}
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: