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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All content on this blog is subject to a Creative Commons Licence
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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?
Latest Tweets
- Study indicates that over 40% of patients do not recall the information on the intervention they consented to. Just… twitter.com/i/web/status/1… 1 day ago
- Scary, knowing a commercial giant like Google is involved, and not sure whether this serves a greater good and/ or… twitter.com/i/web/status/1… 1 day ago
- Must read for all in medical devices: keep reporting your clinical trias as before, while also preparing for report… twitter.com/i/web/status/1… 1 day ago
- Class IIa medical device obtains CE mark. Potentially interesting for patient monitoring in clinical trials.… twitter.com/i/web/status/1… 1 day ago
- EU parliament committee voted to adopt the 2nd MDR corrigendum. #mdr #classI lnkd.in/ecv3upB 2 days ago
Most used tags
- Adverse Event handling
- Clinical benefit
- clinical evaluation
- Clinical Evidence
- Clinical Evidence Plan
- Clinical Investigation
- Clinical Research
- clinical studies
- Clinical Study Population
- Clinical Trial
- Clinical Trial Investment
- clinicaltrials gov
- Controlled Clinical Trial
- Cost Effective
- Country Regulations
- Data-management
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- Informed Decisions
- investigator-sponsor
- Investigator Initiated Trial
- Investigator Sponsored Trial
- ISO 14155
- IST
- IVDR
- Market Access
- Market adoption
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- medical device industry
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- PMCF
- Post-market Observational Study
- Postmarket Clinical Follow-Up
- Postmarket Safet Reporting
- Postmarket Safety Reporting
- Postmarket Studies
- Postmarket Surveillance
- Premarket Safety Reporting
- Premarket Study
- Product Claims
- Publication
- Publication Bias
- Publication Strategy
- Randomized Clinical Trial
- Registry
- Regulatory
- Reimbursement
- science
- Scientific Credibility
- Sponsor
- Vigilance
Tag Archives: MDR
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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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
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
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
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
EU MDR – CAN YOU AFFORT TO WAIT STARTING YOUR CLINICAL TRIAL?
There is no debate that under MEDDEV Rev 2.7/1 Rev. 4 and the MDR there is a higher demand for qualitative clinical evidence on medical device safety and performance before and after they are brought to market (also see my … Continue reading
