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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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