Who is this blogger?
Annet Visscher
My name is Annet Visscher 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.
- +31 26 800 1219Standard time zone:
UTC/GMT +1 hour -
-
Recent Posts
Latest Tweets
Tweets by AnnetMuetstegeMost 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
- Coronavirus
- Cost Effective
- Country Regulations
- COVID-19
- daily practice
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GCP
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- investigator-sponsor
- ISO 14155
- ISO14155
- IVDR
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- performance evaluation
- PMCF
- post-market clinical follow-up
- 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
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: ISO 14155
THE NEW ISO 14155: WHAT CHANGED IN THE END?
With the updated references of harmonised standards for medical devices, ISO 14155: 2020 is THE GCP standard for medical device clinical investigations, and since as of May 26th 2021 the MDR fully applies you may want to familiarize yourself and … Continue reading
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
2 Comments
A NEW VERSION OF ISO 14155: WHAT TO EXPECT?
The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading
THE MEDICAL DEVICE CLINICAL TRIAL ENVIRONMENT IN EUROPE
One of the topics discussed during the Medical Device Clinical Trial Seminar in Taipei, was the current medical device clinical trial environment in Europe and how that is evolving. A short version of my presentation, you can find on SlideShare … Continue reading
CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI
I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the … Continue reading
Clinical evidence under the EU Medical Device Regulation: More firework on the way.
The EU Medical Device Regulation (MDR) and the In Vitro Diagnostic device Regulation (IVDR) entered into force, local governments published guidance how to deal with the new medical device regulations, there is debate on the implementation of the MEDDEV 2.7/1 … Continue reading
Posted in Uncategorized
Tagged clinical evaluation, Clinical Evidence, GDPR, ISO 14155, IVDR, MDR, MEDDEV 2.7/1
Leave a comment
INVESTIGATOR CLINICAL STUDIES: FOUR KEY THINGS TO DO
Last week some-one asked me what it is that industry can and can not do in investigator initiated trials (IITs). The challenge in answering this question goes back to the question who the sponsor – and therefore the one being … Continue reading
Posted in Uncategorized
Tagged Adverse Event handling, Clinical Evidence, Clinical Trial, Declaration of Helsinki, IIT, industry-sponsor, Investigator Initiated Trial, Investigator Sponsored Trial, investigator-sponsor, ISO 14155, IST, Medical Device Directive, Medical Device Regulation, Sponsor
2 Comments
WHERE WILL THE EU MEDICAL DEVICE REGULATION LAND FOR CLINICAL TRIALS?
The proposed EU medical device regulation is designed to lead to better clinical evidence and improved patient safety. Measures such as the scrutiny procedure, improved postmarket surveillance and vigilance, and more devices being classified as high risk, should prevent disasters … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence, Clinical Investigation, Clinical Research, Clinical Trial, Country Regulations, Ethics Committee, ISO 14155, Medical Device Directive, Medical Device Regulation, Medical Devices, Postmarket Clinical Follow-Up, Postmarket Safet Reporting, Postmarket Surveillance, Premarket Safety Reporting, Vigilance
1 Comment
Medical Devices Clinical 