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.
Location and time zone
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Recent Posts
Latest Tweets
- FDA updates Covid-19 clinical trial guidance, incl guidance on emergency informed consent process in prospective tr… twitter.com/i/web/status/1… 16 hours ago
- Adding smell tests may enhance accuracy of temperature screening when checking for covid-19. #medicaldevices… twitter.com/i/web/status/1… 5 days ago
- Updated guidance from the IGJ allows for restart of on-site monitoring in close alignment with the concerning healt… twitter.com/i/web/status/1… 1 week ago
- RCT shows potential for dexamethasone in hospitalised COVID-19 patients! #RCT #clinicaltrial #covid19 #efficacy lnkd.in/gNv898B 2 weeks ago
- Do you know what needs to be done for your medical device under the MDR? #medicaldevice #MDR #clinicalevaluation… twitter.com/i/web/status/1… 3 weeks 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
- Coronavirus
- Cost Effective
- Country Regulations
- 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
- ISO 14155
- IVDR
- Market Access
- Market adoption
- MDCG guidances
- 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
- Reimbursement
- remote monitoring
- risk-based monitoring
- science
- Scientific Credibility
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: Clinical Investigation
COVID-19 CLINICAL EVIDENCE DOWNTIME: HOW TO MAKE USE OF IT!
To date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have … Continue reading
2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS
Nothing could have been more illustrative for the medical device clinical trial environment in Europe than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Investigation, Clinical Research, ISO 14155, MDR, Medical Devices, Monitoring
2 Comments
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
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
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
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
EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE
The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading
WHERE WILL THE EU MEDICAL DEVICE REGULATION LAND FOR CLINICAL TRIALS?
The proposed EU medical device regulation is designed to lead to better clinical evidence and improved patient safety. Measures such as the scrutiny procedure, improved postmarket surveillance and vigilance, and more devices being classified as high risk, should prevent disasters … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence, Clinical Investigation, Clinical Research, Clinical Trial, Country Regulations, Ethics Committee, ISO 14155, Medical Device Directive, Medical Device Regulation, Medical Devices, Postmarket Clinical Follow-Up, Postmarket Safet Reporting, Postmarket Surveillance, Premarket Safety Reporting, Vigilance
1 Comment
