Tag Archives: MDD

CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI

I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the … 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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WHY WAIT UNTIL THE MEDICAL DEVICE DIRECTIVE CHANGES?

The year 2012 has been turbulent for the Medical Device Industry in Europe, with the  lagging economy, but also with the scandals over the breast and hip implants, and Notified Bodies showing malpractices. These scandals resulted in an enhanced speed … Continue reading

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