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)

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