(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 ...
For manufacturers aiming to export electrical equipment to the European market, CE/UKCA Marking is a crucial requirement. CE Conformity Services provides the expertise and support needed to navigate ...
PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...
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 ...
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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