Dear reader, thank you for your continued interest in my post. It has been a turbulent year for Clinical Research in Medical Devices with the debates and amendments to the Medical Device Directive, and much more to come in 2014. I am looking forward to the coming year and wish you Happy Holidays and a prosperous New Year. Annet
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.
Location and time zone+31 26 848 5281Standard time zone:
UTC/GMT +1 hour
All content on this blog is subject to a Creative Commons Licence
- GENERAL DATA PROTECTION REGULATION – 5 CLINICAL ASPECTS
- GLOBALIZATION of MEDICAL DEVICE TRIALS: MUTUAL RECOGNITION of CLINICAL STUDY RESULTS
- MEDDEV 2.7/1 REVISION 4: A HIGHER DEMAND FOR CLINICAL EVIDENCE
- EU MEDICAL DEVICE STUDIES IN 2015: A YEAR OF CONTRAST?
- THE ON-SITE MONITOR: A SPECIES NEARING EXTINCTION?
- Study shows cataract & depression are related. Will IOL implantation reverse this? Kees Den Besten, Thomas Schulz lnkd.in/gKftSrQ 3 days ago
- EMA publishes clinical data on 2 more medicinal products. lnkd.in/gVrzUX7 1 week ago
- Shocking: Over 1300 'better not' treatments without sufficient clinical evidence. lnkd.in/gz2wsRz 1 week ago
- EU Medical Devices Regulation Series on Key Issues lnkd.in/gJ-DSHu 1 week ago
- Whereas the EU medical device regulations are becoming more strict, Trump plans on easing FDA regulations. lnkd.in/gf4WnTB 2 weeks ago
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 daily practice Data-management Data protection Data Transparency Declaration of Helsinki effectiveness Efficacy Ethics Committee EUDAMED 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 Medical Device Directive medical device industry Medical Device Regulation Medical Devices Medical Device training 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