Tag Archives: Clinical Research

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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INFORMED CONSENT – 5 CRITICAL ELEMENTS TO MONITOR

Ensuring proper informed consent in clinical studies is a critical process, that protects the rights, safety, and welfare of human subjects involved. It will require even more attention under the new GDPR and with the globalization of clinical trials. Although … 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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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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CLINICAL EVIDENCE DILEMMAS: IS MY CLINICAL STUDY POPULATION THE RIGHT ONE?

Is my study population the right one, or in other words: Does my clinical study population represent the patients the study product is meant for? An essential question to answer when designing a clinical study to collect clinical evidence regarding product … Continue reading

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MERRY CHRISTMAS & HAPPY NEW YEAR

Dear reader, thank you for your continued interest in my post. It has been a turbulent year for Clinical Research in Medical Devices with the debates and amendments to the Medical Device Directive, and much more to come in 2014. I … Continue reading

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