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      • Performance evaluation of IVDs
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      • FDA relevant documents
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April 25, 2023


Clinical endpoints: Why they are important

By Dr. Bettina MartinApril 25, 2023Leave a comment

When notified bodies identify discrepancies in clinical evaluations, in many cases, these relate to the clinical endpoints. It is, therefore, essential for medical device manufacturers to specify the clinical endpoints precisely and to demonstrate that they have actually been achieved. This article explains what manufacturers should pay particular attention to.

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