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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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