Tag Archives: Clinical benefit

WHAT CLINICAL BENEFIT DO YOU WANT TO PROVE IN YOUR STUDY?

Defining the clinical benefit or the efficacy parameters for your product in a clinical study is a challenging but critical activity: Do I aim to show the effect of product itself or that of a treatment as a whole, what … Continue reading

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EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE

The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading

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