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2020 Results: Exceptional Growth
Excellent Team and Strong Operational Performance We ended 2020 with significant momentum, which is expected to continue in 2021 with a pipeline
Conducting clinical investigations successfully
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
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
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
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
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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