What is a medical device risk management plan?

Date:2023-01-09
A medical device risk management plan is a set of documented processes that a medical device manufacturer implements in order to identify, assess, monitor and control the risks associated with the use of the device. It is designed to ensure the safety of patients and provide assurance that the device design meets the intended use. The plan typically covers areas of design and development, production, post-market surveillance and complaint handling.
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