Following the publication of the MEDDEV 2.7-1 in 2016 rev 4 and subsequently Medical Device Regulation 2017/745 (MDR), medical device manufacturers
Excellent Team and Strong Operational Performance We ended 2020 with significant momentum, which is expected to continue in 2021 with a
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular
The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of
Leipzig Interventional Course (LINC) is scientific live course designed to provide a global platform permitting the interdisciplinary discussion of
Checkout our LinkedIn profile.
Checkout our selection of resources about medical devices and clinical writing.
AKRN Social Network