Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices is a systematic process used to assess the safety, performance, and clinical benefits of a medical device throughout its lifecycle. It is a regulatory requirement in many global markets, including the EU, UK, and other major jurisdictions, to demonstrate that a device meets applicable safety and performance standards before and after it enters the market.Clinical evaluation is a structured and ongoing assessment of clinical data related to a medical device. It involves collecting, analyzing, and interpreting relevant scientific and clinical information to verify that the device performs as intended and does not pose unacceptable risks to patients or users.
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