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  • akashranpura replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    When looking at risk-benefit analysis, one is basically answering the question “is the risk worth it?” To answer this question a thorough analysis needs to be done on the trade-offs of the product. Statistical measures need to be taken in order to fully understand and implement the risks versus reward of the product. When dealing with medical devices the most common risk examined is the chances of the product being fatal or harming the patient to a large degree. However, if the reward is that most people will benefit tremendously from this product, certain executive level decisions need to be made. The magnitude and type of benefits the patient will experience must be examined to a certain degree in this study. Also the length of how effective the product will be is something that should also be taken into consideration.