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
-
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… 18 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: Postmarket Safety Reporting
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 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
