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thuytienlecao replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major phases: risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, evaluation of overall residual risk acceptability, risk management report, production&post-production.
1. Risk analysis: Define scope –> specify the intended use –> identify hazards and hazardous situations –> estimate risk. Risk=severity x occurrence
2. Risk evaluation: deciding which risks are acceptable/unacceptable
3. Risk control: reduce and mitigate unacceptable risks by considering product design, protective measures, labelings
4. Residual risk evaluation: re-evaluate the resulting risks, re-estimate risks from implemented risk controls.
5. Risk/benefit analysis
6. Evaluation of overall residual risk acceptability: evaluate the entire device in all situations, not just hazardous situation.
7. Risk management report: summarize risk activities.
8. Production and post-production: keep risk management records up to date.Reference: https://blog.greenlight.guru/iso-14971-medical-device-risk-management