mdevicecorp
https://www.meddevicecorp.com/clinical-evaluation-report/
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Medical device Manufacturers of all risk class and type must clinically evaluate the device safety and performance before applying for Notified Body for CE Marking. To conduct clinical evaluation as per MDR Article 61, the manufacturer has to examine clinical data sourced from various sources in order to conclude the subjected medical device is safe and performing good for the intended purpose. https://www.meddevicecorp.com/clinical-evaluation-report/
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JULY 23, 2021
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