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
- 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
- New pharmaceutical industry Code of Conduct criticized for not addressing the high prices of medicines. lnkd.in/e4HmrJj 2 days ago
- Strict regulations hindering clinical trials evaluating known drug treatments. Let's not go there with medical devi… twitter.com/i/web/status/1… 5 days ago
- RT @MedtechAmanda: New #EUIVDR demands for companion diagnostics are high and having sufficient time to prepare for compliance is vital. Bu… 5 days ago
- Study indicates over 20% of clinical trial results are still not published by study sponsors in spite of threatenin… twitter.com/i/web/status/1… 1 week ago
- Clinical trial indicates pro's and con's on hypertensive drug treatment: who will decide what the best treatment i… twitter.com/i/web/status/1… 2 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
- 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: 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
