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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
Excellent Team and Strong Operational Performance We ended 2020 with significant momentum, which is expected to continue in 2021 with a pipeline
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 in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European
Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A
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 a European Medical Device and In-Vitro Diagnostics CRO that can help your company get clinical trial approval / EU market approval To
There’s a common misconception among many medical device manufacturers that obtaining a CE mark is now too hard, too costly, and too
Checkout our selection of resources about medical devices and clinical writing.
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