Tag Archives: Clinical Investigation

THE MEDICAL DEVICE CLINICAL TRIAL ENVIRONMENT IN EUROPE

One of the topics discussed during the Medical Device Clinical Trial Seminar in Taipei, was the current medical device clinical trial environment in Europe and how that is evolving. A short version of my presentation, you can find on SlideShare … Continue reading

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EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

Last week Glenis Willmott was announced to be the new rapporteur for the Medical Device Directive revision. For me that raised the question what effect this will have on the clinical research aspects of the proposed Medical Device Regulation. Given … 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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