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  • jjp93 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 5 months ago

    For a low severity of a risk, I would either choose acceptance or mitigation depending on the situation. If the risk had options of making it less severe or less likely to occur through mitigation, I would say this is the better option. If there is a risk which cannot be solved through mitigation, then acceptance would be the next option because of the low severity of the risk. For a high severity of a risk, I would choose avoidance because of how high the risk is for the product. Going forward with the risk through acceptance would cause many issues and with the severity of the risk, it’ll be harder to mitigate the issue as well (but this would be a the second option). Out of these options, I believe acceptance and transference would not reduce the risk level. Acceptance would be used when there is a very low severity of the risk while transference would be used when this risk cannot be avoided but has a major risk so protection through transference would be a better option.