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  • msc52njit-edu replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 9 months ago

    Based on the options for Risk Management, choosing mitigation would be my selection for a low severity risk. If the risk is not severe there can be a way to mitigate the risk to reduce the severity level to a point where the risk may not affect your product. I do not think that you should just accept the risk, and if the risk can not cause severe harm to the patient then it would be best to deal with the risk as best as you can and try to find any options that can decrease the affect it may have. When dealing with a high severity risk I would choose to manage it through avoidance. Accepting a high severity risk can have dangerous consequences for the patients, can cause harm, and can cost the company money in lawsuits. The best option is to try and avoid it all together not put lives and your company at risk. Mitigation may help but if the risk is too severe there may not be a lot of options that can significantly reduce the risk to a safe level. I do not think acceptance will reduce the risk level because there are no actions being taken to make it safer and the risk is just left to happen eventually. Acceptance can only be used when the risk is so insignificant that the affect would not cause any noticeable outcome to the patient.