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
All content on this blog is subject to a Creative Commons Licence
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Recent Posts
- INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
- Informed Consent and Clinical Trials: will we ever learn?
- THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES
- A NEW VERSION OF ISO 14155: WHAT TO EXPECT?
- MEDICAL DEVICE CLINICAL EVIDENCE HIGHLIGHTS 2018/ 2019: ROARING TIMES IN EUROPE
Latest Tweets
- EU Commission issues a new site suitability template for clinical trials under the new clinical trial regulation.… twitter.com/i/web/status/1… 5 days ago
- DEKRA the first Notified Body designated under the IVDR. #medicaldevices #ivdr lnkd.in/eT5qxqU 1 week ago
- The updated version of ISO 14155 is coming soon. The ACS team will attend a training on the changes in January 2020… twitter.com/i/web/status/1… 1 week ago
- Long term clinical study indicates that deep brain stimulation benefits people with severe depression unresponsive… twitter.com/i/web/status/1… 1 week ago
- Informed consent, e-signature (light blue) vs print to sign (dark blue): any relation to dataprivacy?… twitter.com/i/web/status/1… 1 week 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
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- Informed Decisions
- investigator-sponsor
- Investigator Initiated Trial
- Investigator Sponsored Trial
- ISO 14155
- IST
- IVDR
- Market Access
- Market adoption
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- medical device industry
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- PMCF
- 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
- Registry
- Regulatory
- Reimbursement
- science
- Scientific Credibility
- Sponsor
- Vigilance
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