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zbw2 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts will likely be handled with acceptance or transference regardless of the risk level, unless the risk is too high, in which case the device probably too risky to make in the first place. for less critical parts of a device, mitigation or avoidance can be utilized as these components are less likely to be essential to the devices main function and can therefore be changed or omitted.