This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
Company focusing resources on near-term commercial milestones; European CE Mark process and Healthcare Research revenue ...
The European Commission issued new rules on 24 September 2013 that establish a new EU process for designating and monitoring Notified Bodies, establishing the basis for withdrawing such a designation ...
(click to enlarge)Average total FDA review days from filing to approval for original PMAs and panel track PMA supplements. Some of these products can now be reviewed for marketing in Europe within 45 ...
Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation ...
CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to commercialization aXess™ reduces the need for vascular access interventions ...
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