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  • hc255 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 6 months ago

    To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that aim to move around the risk completely. It is also worth mentioning that the severity may be high however if the occurrence is low then there is no need to accept the risk. I would propose to put methods in place to mitigate the issue if it were to arise in a case. An occurrence of risk adds a big factor when considering which plan of action is best suitable. Through risk management planning, the risks whether they are of high/low severity can be dealt with. Acceptance may not reduce the risk level out of the options listed above unless there is a plan in place to deal with the potential issues. Risk level shouldn’t reduce. I believe that comes through the design protocols in place.