This is the second installment of my series on medical device clinical evaluation. I suggest reading the first part (How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities – http://www.medicaldevice.expert/europe/european-commission/medical-device-regulation/how-to-perform-a-clinical-evaluation-of-medical-devices-part-1-overview-and-sample-of-activities/0 to have a better understanding of the concepts so the understanding of this part is easier).
One of the fundamental discussion related to clinical evaluation is: Level of clinical evidence and what sufficient clinical evidence means? The attached document provides a discussion of the scientific basis to determine level and sufficiency of clinical evidence.
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