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