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hm243 replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 8 years, 2 months ago
As stated previously, the risk-benefit analysis is an important, when determining the benefits and risks that need to be considered for a product. One of the factors that is considered in the analysis is postmarket data. When the product is used in reality, a better assessment can be made of the risks and benefits it poses. With the collection of postmarket data, it will help to identify more benefits and risks for the product and how it affected the patients. FDA has the ability to request post-approval studies. With the data that is collected once the product hits the market will help to improve the benefits and allow for fewer risks in the product. This postmarket data will also take into perspective the response of the patients and how the product affects them. This will allow them to improve the product accordingly to get the best results. Along with the other factors mentioned, risk-benefit analysis can improve and help to create most effective product.