Who is this blogger?
Annet Muetstege - Visscher
My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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Recent Posts
- 6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
- INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
- Informed Consent and Clinical Trials: will we ever learn?
- THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES
- A NEW VERSION OF ISO 14155: WHAT TO EXPECT?
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Category Archives: Uncategorized
6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
Update 27-NOV-2019: The EU commission issued a second corrigendum, which upon acceptance by the parliament will give manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Evidence, MDD, MDR, MEDDEV 2.7/1, Medical Devices, Postmarket Studies, Premarket Study
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INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
PART I – Patient Safety Since the hip and pip scandals, and the subsequent changes in the EU regulatory environment there is no denial that there are increasing clinical evidence demands for medical devices in Europe. But what is driving … Continue reading
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
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
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
CLINICAL EVIDENCE DILLEMAS: HOW LONG SHOULD PATIENT FOLLOW-UP BE?
The Implant Files touched upon one of the toughest dilemma’s designing a clinical study: How long do patients treated with a medical device need to be followed in a clinical study before one can say the device is safe and … Continue reading
