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dag56 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 5 months ago
In general, I agree with the above comments that state that lower risks can mostly reasonably be managed by using the strategies acceptance and/ or mitigation. This makes sense because if it is relatively low risk, the consumer most likely will not experience any ill effects and excessive mitigation attempts could cause excessive funds to be spent with little reward.This is in contrast to hazards that fall into high severity of risk which can mostly reasonably be managed by using the strategies transference and/ or avoidance. This makes sense because transferring a high severity of risk will pass responsibility off to a third party. This is always preferable in higher risk situations for liability reasons.
However, I would like to add that sometimes acceptance of higher severity of risk products can (but very rarely) fall under the acceptance/ mitigation categories as well. This can primarily be seen in the strong chemotherapy drugs used to treat cancer. Standing alone, these potent platinum drugs can easily kill a human being, however, doctors bet on the gamble that the cancer cells die before the patient is killed. This is an example of acceptance of risk because there is currently no better way to treat a guaranteed fatal condition.