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Heart Transplantation Clinical Trials in Spain
Heart transplantation: aetiology and history Heart transplantation is the surgical replacement of a diseased, failing heart with a compatible and
IVD Clinical Performance Studies
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
What is the IVDR?
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
ISO 20916 new international standard for IVDs
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
ISO 20916 for IVD vs. ISO 14155 for Medical Devices
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
Dermal fillers as medical devices under the MDR
Introduction to dermal fillers Dermal fillers are injectable soft tissue substances used in aesthetics to improve skin appearance and minimize
Collaboration with the Master in Therapeutic Targets
The University of Alcala was founded in 1499 and is one of the oldest universities in Europe. Several distinguished members of the Spanish culture
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
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