Who is this blogger?
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.
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All content on this blog is subject to a Creative Commons Licence
- 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 tagsAdverse 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: Informed Consent
The Dutch Health Inspection (IGZ) organized an invitational conference on clinical research with medical devices end of last year. Representatives of the different stakeholders, such as manufacturers, competent authorities, Ethics Committee’s, and health care providers were present during this conference … Continue reading →
Ensuring proper informed consent in clinical studies is a critical process, that protects the rights, safety, and welfare of human subjects involved. It will require even more attention under the new GDPR and with the globalization of clinical trials. Although … Continue reading →
The year 2016 has been a very interesting one from clinical perspective with many developments in the EU medical device regulatory environment, and I am sure we are facing an even more interesting one coming up: The latest draft of … Continue reading →
As mentioned in my previous post on the MEDDEV 2.7/1 revision 4, the second quarter of 2016 is characterized by several big steps from clinical evidence perspective: Besides the publication of the new version of the MEDDEV 2.7/1, consensus was … Continue reading →
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 →
Looking over a year’s worth of events, there have been several in 2014 at European as well as national level that will have an impact on medical device clinical studies in Europe moving into 2015. Below you find a selection: March … Continue reading →
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 →