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  • Getting Started
  • User Guide
  • IEC 62304 Guide
  • API Reference
  • FAQ
  • Troubleshooting
  • GitHub
  • PyPI

Section Navigation

  • What is IEC 62304?
  • Software Safety Classifications
  • Software Development Lifecycle
  • Traceability Requirements
  • Risk Management Integration
  • IEC 62304 Guide

IEC 62304 Guide#

This section provides an educational overview of IEC 62304 and how jamb supports its traceability and test verification requirements.

  • What is IEC 62304?
    • Purpose
    • Scope
    • Regulatory Context
    • Relationship to Related Standards
    • SaMD vs SiMD
  • Software Safety Classifications
    • Three Classes
    • Required Activities by Class
    • How jamb Supports All Classes
  • Software Development Lifecycle
    • The Nine Process Areas
    • The V-Model
  • Traceability Requirements
    • Bidirectional Traceability
    • How jamb’s Document DAG Implements Traceability
    • Suspect Link Detection as Change Impact Analysis
    • Trace Completeness with jamb validate
    • Test Record Contents (Clause 5.7.5)
    • Further Reading
  • Risk Management Integration
    • ISO 14971 Relationship
    • HAZ and RC Documents in jamb
    • Risk Controls to Software Requirements Tracing

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