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su65 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 8 months ago
High severity risks are unacceptable because they can cause severe harm to patients. Avoidance or mitigation would be good for high severity risks. Considering risks are high, To avoid them or to eliminate them is a good option rather than taking any chances. Mitigation or acceptance could be choosen for low severity risks because its okay to accept or to mitigate the risk so that the benefit would be good considering its low risk. Transferance can be done for low severity risks where those risks cannot pose core competency risks to the company .