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GUIDANCE TO RISK MANAGEMENT RISK MANAGEMENT FOR MEDICAL DEVICES
FRAMEWORK & PLANNING The risk supervision process in compliance with the guidance like FDA or ISO needs to be authenticated by this framework.
ANALYSIS Device manufacturers give direct efforts towards the intended use of the product, it will be overviewing the related perils.
EVALUATION Identifying the severity and probabilities of prospects will help in quantifying and deciding the risk always tackled first.
CONTROL Once the venture has been identified, the next step is to regulate it, and its aims to mitigate or magnitude of risk to an agreeable level.
MAKE REPORTS The next one is to document the effectiveness of the controlling actions, keeping an eye after implemented the process.
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