(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 ...
CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to ...
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 ...
Femasys Inc. announced the achievement of CE mark certification for the FemBloc delivery system, marking it as the first regulatory approval in the world for a non-surgical permanent birth control ...
Since the European Union’s main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU’s rules in those areas would be clear and straightforward.
(MENAFN- GetNews) Getting your custom CE certification for the Lead Machine is pretty much essential if you want to sell in Europe. It basically proves your product meets all those health and safety ...
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 ...
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