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Institute Orthopedic RizzoliInformation Sheet & Consent FormINFORMATION SHEET AND CONSENT FORM (Applicable to patients capable of giving personal consent) INFORMATION Speedier Sir×Madam, A medical
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What is 15 clinical evaluations of?
15 clinical evaluations are reports on the clinical performance and safety of a medical device.
Who is required to file 15 clinical evaluations of?
Manufacturers of medical devices are required to file 15 clinical evaluations.
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15 clinical evaluations are filled out by collecting data from clinical studies, literature reviews, post-market surveillance, and other sources.
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The purpose of 15 clinical evaluations is to demonstrate the safety and performance of a medical device.
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Information such as patient demographics, study designs, adverse events, and clinical outcomes must be reported on 15 clinical evaluations.
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