Tag Archives: MEDDEV 2.7/1

MEDICAL DEVICE CLINICAL EVIDENCE HIGHLIGHTS 2018/ 2019: ROARING TIMES IN EUROPE

From a medical device clinical evidence perspective, we are looking back on a turbulent 2018 and forward to an exciting 2019. Highlights of 2018 included, the GDPR becoming effective, with more strict regulations on data handling and the content of … Continue reading

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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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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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Clinical evidence under the EU Medical Device Regulation: More firework on the way.

The EU Medical Device Regulation (MDR) and the In Vitro Diagnostic device Regulation (IVDR) entered into force, local governments published guidance how to deal with the new medical device regulations, there is debate on the implementation of the MEDDEV 2.7/1 … Continue reading

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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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