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Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means

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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 – How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities – Medical Device Expert News 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.


EU-MDR-Level-of-clinical-evidence-and-what-sufficient-clinical-evidence-meansDownload

Posted at Marcelo's Medicaldevice.expert website...

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