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
-
Recent Posts
- EU MDR DEADLINE MAY 2020: CLINICAL EVIDENCE STATE OF AFFAIRS AT YEAR’S END
- 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
Latest Tweets
- "All tests have error rates". Question is to what degree to make it acceptable. We will see when the IVDR arrives.… twitter.com/i/web/status/1… 4 days ago
- UK to lead the way, ensuring that medical devices will meet the highest standards of regulation, boosting patient s… twitter.com/i/web/status/1… 1 week ago
- Should we also monitor animal regulatory studies to prevent fraude? #regulatorystudies #monitoring #fraude lnkd.in/eHz3Kk9 1 week ago
- ISO 14155: 2020. One step closer to publication, is your organisation prepared? #clinicalinvestigation #iso14155 lnkd.in/d4EHJZN 1 week ago
- Patients victims of the MDR due to threatening shortage instead of profiting from safer medical devices later this… twitter.com/i/web/status/1… 1 week 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
- ISO 14155
- IST
- 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
- Regulatory
- Reimbursement
- science
- Scientific Credibility
- Sponsor
- Vigilance
Tag Archives: Patient Outcomes
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
PUBLISH OR PERISH
Although retractions may sometimes suggest otherwise, publication of clinical data is how to obtain the return on a clinical trial investment. The clinical trial investment is substantial as the process to collect clinical evidence from research sites is involved and … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence Plan, Clinical Trial, Clinical Trial Investment, clinicaltrials gov, Informed Decisions, Market Access, Market adoption, medical device industry, Medical Devices, Patient Outcomes, Publication, Publication Bias, Publication Strategy, science, Scientific Credibility
2 Comments
