![]() It means there are different levels of risks associated with a device and we should estimate each risk for its acceptability to use on humans. There are different levels of severities for different types of harms for a particular medical device, based on its intended use. If we came to know that there is a probability of occurrence of harm, associated with the use of particular medicine or device, then we should estimate the severity of that harm. ![]() This resource provides insight into how the FDA performs a benefit-risk assessment and what factors you should consider in assessing the potential harms of your device. Similar way, the products which we are used for the treatment of patients having some side effects or harms, but we should use them to save the lives. Medical Device Benefit Risk Assessments Benefit-risk assessments are important tools that help regulators determine whether or not the benefits of your device outweigh the risks. There is a saying, “A bitter pill to swallow”, which means that we have to accept it even though it is very unpleasant. So, we should compare the benefits with the risks, to determine the acceptability of risks of a particular medical device. Medical devices are developed for certain medical purposes, means they have certain benefits. Risk Benefit Analysis of Medical Devices is tough and interesting.
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