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  • mark abdelshahed replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 7 years, 5 months ago

    Another risk factor to be considered for making decisions concerning product availability, compliance and enforcement is factors for the assessment of medical device benefits. Benefit, as described by the potential benefit factors, may change over time. FDA may assess the extent of benefit of a device by considering factors like: type of benefits, magnitude of benefits, likelihood of patients experiencing one or more benefits, duration of effects, patients perspective on benefit, benefit factors for healthcare professionals or caregivers, and medical necessity. It is important to compare and contrast the benefits and risks identified based on the available information, in order to see if the benefits of this specific device is more than the risks of it or not.