Who is this blogger?
Annet Muetstege - Visscher
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
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Recent Posts
- 6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
- 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?
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- Adverse Event handling
- Clinical benefit
- clinical evaluation
- Clinical Evidence
- Clinical Evidence Plan
- Clinical Investigation
- Clinical Research
- clinical studies
- Clinical Study Population
- Clinical Trial
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- clinicaltrials gov
- Controlled Clinical Trial
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- Declaration of Helsinki
- effectiveness
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- Investigator Sponsored Trial
- ISO 14155
- IST
- IVDR
- Market Access
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- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- medical device industry
- Medical Device Regulation
- Medical Devices
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- NICE
- Patient Outcomes
- Patient Safety
- PMCF
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- Postmarket Clinical Follow-Up
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- Publication
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- science
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Tag Archives: Regulatory
FOUR (NOT) TO DO’S TO PREVENT PAPER WITHDRAWAL
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 →