iec62304-lifecycle-manager

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Medical device software lifecycle management skill implementing IEC 62304 requirements

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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