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: Clinical Investigation
EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED
Last week Glenis Willmott was announced to be the new rapporteur for the Medical Device Directive revision. For me that raised the question what effect this will have on the clinical research aspects of the proposed Medical Device Regulation. Given … Continue reading
EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE
The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading
WHERE WILL THE EU MEDICAL DEVICE REGULATION LAND FOR CLINICAL TRIALS?
The proposed EU medical device regulation is designed to lead to better clinical evidence and improved patient safety. Measures such as the scrutiny procedure, improved postmarket surveillance and vigilance, and more devices being classified as high risk, should prevent disasters … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence, Clinical Investigation, Clinical Research, Clinical Trial, Country Regulations, Ethics Committee, ISO 14155, Medical Device Directive, Medical Device Regulation, Medical Devices, Postmarket Clinical Follow-Up, Postmarket Safet Reporting, Postmarket Surveillance, Premarket Safety Reporting, Vigilance
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