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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
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
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
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
Free Resources for the Medical Device Industry to Fight COVID-19
Do you want to place your medical device or in-vitro diagnostic device on the market, but you have limited resources to do so? We prepared this
ÅKRN is Joining The Fight Against COVID-19
ÅKRN is a European Medical Device and In-Vitro Diagnostics CRO that can help your company get clinical trial approval / EU market approval To
The Path to CE-mark
There’s a common misconception among many medical device manufacturers that obtaining a CE mark is now too hard, too costly, and too
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