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Classification of IVD under the IVDR
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
What You Need to Know About the New ISO 14155:2020 Standard
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
European Medical Device Law
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
What are the MEDDEV Guidance Documents?
MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European
A Brief Cardiovascular Glossary
Cardiology is a branch of medicine that deals with disorders of the heart and some parts of the circulatory system. Cardiology is concerned with
Cardiovascular KOLs
Key Opinion Leaders (KOLs) are experts and advisors on a specific topic. Due to KOLs’ professional background, their opinion is respected and
List of Spanish Clinical Research Institutions
A clinical research institution is any center that conducts clinical studies. Spain is a reference country for performing clinical trials. In
In Vitro Diagnostic (IVD) devices and European CE Marking
The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European
What is a clinical trial?
A clinical trial is any research conducted in humans evaluating the performance and safety of an investigational product. James Lind conducted the
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