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.
Location and time zone
All content on this blog is subject to a Creative Commons Licence
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Recent Posts
- CORONAVIRUS AND CLINICAL STUDIES: WHAT TO DO?
- 2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS
- EU MDR DEADLINE MAY 2020: CLINICAL EVIDENCE STATE OF AFFAIRS AT YEAR’S END
- 6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
- INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
Latest Tweets
- For anyone involved in medical devices. Mind you “just a proposal, no law yet". #medicaldevice #mdr lnkd.in/eV6BBsc 8 hours ago
- Commission postpones application of the MDR. #mdr #medicaldevice lnkd.in/e9-Tf-c 1 day ago
- FDA updates guidance on clinical trial conduct during Covid-19 pandemic. #clinicaltrial #coronavirus #covid… twitter.com/i/web/status/1… 5 days ago
- EU Commission working on a proposal to delay the MDR date of application by one year. Use that time well to collect… twitter.com/i/web/status/1… 1 week ago
- CEN & CENELEC in cooperation with the EU, temporarily providing a number of EU standards related to personal protec… 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
- ISO 14155
- IVDR
- Market Access
- Market adoption
- MDCG guidances
- 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
- Reimbursement
- remote monitoring
- risk-based monitoring
- science
- Scientific Credibility
- Site Monitoring
- Sponsor
- Vigilance
Category Archives: Uncategorized
CORONAVIRUS AND CLINICAL STUDIES: WHAT TO DO?
By now the Coronvirus outbreak is affecting everyday life worldwide (see latest statistics Johns Hopkins University), and to avoid patient exposure or to reduce the burden on clinical services it also started impacting clinical trials; their execution, monitoring, and publications. … Continue reading
2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS
Nothing could have been more illustrative for the medical device clinical trial environment in Europe than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Investigation, Clinical Research, ISO 14155, MDR, Medical Devices, Monitoring
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EU MDR DEADLINE MAY 2020: CLINICAL EVIDENCE STATE OF AFFAIRS AT YEAR’S END
With less than 5 months to go until application, the development of guidance on the clinical evidence collection process under the EU MDR is progressing scarily slow. The updated overview from December suggests we theoretically will get some more clinical … Continue reading
6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?
Update 18-DEC-2019: The EU parliament adopted the second MDR corrigendum, giving manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as the other medical devices with a … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Evidence, MDD, MDR, MEDDEV 2.7/1, Medical Devices, Postmarket Studies, Premarket Study
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INCREASED CLINICAL EVIDENCE DEMANDS FOR MEDICAL DEVICES IN EU: MORE OR BETTER?
PART I – Patient Safety Since the hip and pip scandals, and the subsequent changes in the EU regulatory environment there is no denial that there are increasing clinical evidence demands for medical devices in Europe. But what is driving … Continue reading
THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES
The medical device regulatory environment in Europe is moving, but not always as timely and as clear as one would wish, certainly not from clinical perspective. The MDR/ IVDR Rolling plan has been updated and mentions clinicals a few times, … Continue reading
