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