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.

Best practice:

Link risk controls directly to product requirements, as “safety requirements”. Why? Because requirements will be tracked, verified, and change-controlled. As development progresses, these links need to stay accurate.

This is where MatrixReq helps. Our ALM platform supports:

✓ Live links between risks, requirements, tests, and outputs

✓ Real-time dashboards of risk control activities

✓ Alerts when items change and impact traceability

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