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