Matrix Requirements and Galen data join forces to become Matrix One
ISO 14971 - Risk Management
Risk management is not complete without traceability, ISO 14971 is clear on risk management process we need to implement:
Risk Analysis
Risk Evaluation
Risk Controls process
Residual Risk evaluation
Risk Management review
Production & Post-prod activities
IEC 62304 adds another layer:
System requirements
Software requirements
Software system tests
Risk Control measures in software
All must be connected. Traceability ensures completeness. It allows teams to maintain consistency as designs evolve. It provides visibility into what’s controlled, tested, verified.
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