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  • pv223 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 4 months ago

    For high level risks, I would do my best to mitigate the risk in an attempt to decrease the severity of the risk and then would try to employ transference to see if anyone else can do something to circumvent the risk. If not, I would employ avoidance to circumvent the risk as best I can. For low level risks, I would either try to mitigate the risk in an attempt to make it not a risk at all, or I would employ transference so someone else can employ any strategies they have to take care of the risk.

    Out of all four methods, I would say that risk acceptance does nothing to affect the risk as you are just accepting it for what it is and not not doing anything else to try and reduce it. The only time I would employ this method is for low level risks that would not affect the product too negatively if they did come into play.