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
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: Vigilance
MEDICAL DEVICE POSTMARKET SURVEILLANCE IN EUROPE – SIMPLE?
The vote of the ENVI committee to the Medical Device Regulation proposal has been postponed until September. Given the Council’s focus on notified body oversight and the process for clinical investigations, however, I do not anticipate many changes regarding the … 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
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