Tag Archives: Registry

DUTCH HEALTH INSPECTION – THE 4 KNOWS OF THE CONFERENCE ON CLINICAL TRIALS WITH MEDICAL DEVICES

The Dutch Health Inspection (IGZ) organized an invitational conference on clinical research with medical devices end of last year. Representatives of the different stakeholders, such as manufacturers, competent authorities, Ethics Committee’s, and health care providers were present during this conference … Continue reading

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EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017

The year 2016 has been a very interesting one from clinical perspective with many developments in the EU medical device regulatory environment, and I am sure we are facing an even more interesting one coming up: The latest draft of … Continue reading

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5 CRITICAL ELEMENTS IN HEALTH ECONOMIC OUTCOMES RESEARCH

Driven by the current financial crises and the rising health care cost, analyses on the estimated costs of treatments in relation to their expected health benefits have become increasingly important in decision making the last few years. Decisions whether or … 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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