Tag Archives: clinical studies

THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES

The medical device regulatory environment in Europe is moving, but not always as timely and as clear as one would wish, certainly not from clinical perspective. The MDR/ IVDR Rolling plan has been updated and mentions clinicals a few times, … Continue reading

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A NEW VERSION OF ISO 14155: WHAT TO EXPECT?

The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading

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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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GDPR: DOES IT IMPACT YOUR CLINICAL STUDY?

It is hard to miss, but as of May 25, 2018, the GDPR becomes effective. Although collection and review of personal data and clinical studies have gone hand-in-hand for decades and therefore I do not expect major changes, the devil … Continue reading

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