Who is this blogger?
Annet Visscher
My name is Annet Visscher 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.
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Tweets by AnnetMuetstegeMost 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
- COVID-19
- daily practice
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GCP
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- investigator-sponsor
- ISO 14155
- ISO14155
- IVDR
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- performance evaluation
- PMCF
- post-market clinical follow-up
- 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
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: Post-market Observational Study
HOORAY: EU MEDICAL DEVICE CLINICAL TRIAL GUIDANCE ONE MINUTE TO MIDNIGHT!
You probably did read it by now, but just in case, herewith a few items that stood out for me while reading the EU Q&A for clinical investigations under the MDR ((MDCG 2021-6) published jst before the May 26th deadline. … Continue reading
A NEW VERSION OF ISO 14155: WHAT TO EXPECT?
The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading
5 CRITICAL ELEMENTS IN HEALTH ECONOMIC OUTCOMES RESEARCH
Driven by the current financial crises and the rising health care cost, analyses on the estimated costs of treatments in relation to their expected health benefits have become increasingly important in decision making the last few years. Decisions whether or … Continue reading
WHY WAIT UNTIL THE MEDICAL DEVICE DIRECTIVE CHANGES?
The year 2012 has been turbulent for the Medical Device Industry in Europe, with the lagging economy, but also with the scandals over the breast and hip implants, and Notified Bodies showing malpractices. These scandals resulted in an enhanced speed … Continue reading
Medical Devices Clinical 