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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
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
ISO 14155 Standard vs. FDA Medical Device Regulations
Background The ISO 14155 standards were created to clarify the design, conduct, recording and reporting of clinical investigations carried out in
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