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
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- Ethics Committee
- EUDAMED
- Europe
- GCP
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- 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: eConsent
EU MEDICAL DEVICE STUDIES IN 2015: A YEAR OF CONTRAST?
Happy New Year! Indeed the year 2015 did become an interesting one looking at it from an EU medical device study perspective. Especially since some of the events seem to create areas for tension: More transparency on clinical data, but … Continue reading →