Who is this blogger?
Annet Muetstege
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
+31 26 848 5281Standard time zone:
UTC/GMT +1 hourAll content on this blog is subject to a Creative Commons Licence
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Recent Posts
- DUTCH HEALTH INSPECTION – THE 4 KNOWS OF THE CONFERENCE ON CLINICAL TRIALS WITH MEDICAL DEVICES
- INFORMED CONSENT – 5 CRITICAL ELEMENTS TO MONITOR
- EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017
- MUTUAL ACCEPTANCE OF CLINICAL STUDY DATA IN DAILY PRACTICE
- GENERAL DATA PROTECTION REGULATION – 5 CLINICAL ASPECTS
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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 Happy New Year Health Care Market Health Economic Model Health Economic Outcomes Health Technology Assessment IIT industry-sponsor Informed Consent Informed Decisions investigator-sponsor Investigator Initiated Trial Investigator Sponsored Trial ISO 14155 IST Market Access Market adoption MDD MDR MEDDEV 2.7/1 Medical Device Directive medical device industry Medical Device Regulation Medical Devices Monitoring NICE Patient Outcomes Patient Safety 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 Randomized Controlled Trial RCT Registry Regulatory Reimbursement science Scientific Credibility Sponsor Vigilance
Tag Archives: Regulatory
FOUR (NOT) TO DO’S TO PREVENT PAPER WITHDRAWAL
The vote regarding the proposed Medical Device Regulation is once more postponed, so we will need some more patience before knowing where we are heading in Europe with the Medical Device Directive. One thing, however, speaks clearly from the proposal … Continue reading →
