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  • ap499 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 9 months ago

    As it was discussed in the slides by dr.simon, Risk management plan identifies and evaluates all the risk. One method that analyzes risk is by FMECA which stands for Failure Mode Effects and Criticality Analysis. Then documentation reviews take place where the list of all risks are assessed and evaluated through FMECA. A solution is to the risk is analyzed and checked or re-evaluated twice to measure if risks are dealt with properly.