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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
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
List of KOLs in Cardiovascular
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
The 4 Pillars of Successful CER Writing
Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A
What is a Medical Device?
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
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