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
Latest Tweets
- lnkd.in/gapfs8V 1 day ago
- Medical device study well on its way. Very interested to see the outcome. lnkd.in/eVq4VKW 1 week ago
- Clinical study indicates contraceptive device may contribute to stress in women. lnkd.in/dbbNXYe 2 weeks ago
- MHRA issues updated guidance for metal-on-metal hip devices. lnkd.in/ggjAJAZ 3 weeks ago
- Study indicates 66 treatments are better not applied since they are not cost-effective. lnkd.in/gHaT5ht 3 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 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
Category Archives: Uncategorized
MUTUAL ACCEPTANCE OF CLINICAL STUDY DATA IN DAILY PRACTICE
During the congress on clinical trials for medical devices in Berlin, I spoke on the mutual acceptance of clinical trial data. A short version of my presentation you can find on SlideShare: Globalization of Clinical Trials: Mutual acceptance of Medical … Continue reading
GLOBALIZATION of MEDICAL DEVICE TRIALS: MUTUAL RECOGNITION of CLINICAL STUDY RESULTS
I am looking forward to the International Congress on Clinical Trials for Medical Devices in Berlin later this month, where I will be talking about the globalization of clinical trials and mutual acceptance of foreign clinical data for regulatory and … Continue reading
Posted in Uncategorized
Tagged bridging studies, clinical studies, Clinical Trial, Medical Devices
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MEDDEV 2.7/1 REVISION 4: A HIGHER DEMAND FOR CLINICAL EVIDENCE
In Europe the second quarter of 2016 is characterized by several big steps from clinical perspective: In April the General Data Protection Regulation (GDPR) entered into force, in June consensus was reached on the new Medical Device Regulation (MDR), and … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Evidence, GDPR, MDR, MEDDEV 2.7/1, Medical Device Regulation, Medical Devices, PMCF
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