European rules for obtaining CE marking on products sold to EU Member States or in the EEA - conditions and product ...

In its letter to the European Commission, the European Organisation of Technical Assessment (EOTA) and stakeholders in the ...

(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 ...

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.

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 ...

Certification of Hexadrone’s TUNDRA 2.1 by Applus+ Laboratories confirms compliance with EU Regulation 2019/945 and stre ...

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 ...

LANCASTER, Pa., Feb. 25, 2025 /PRNewswire/ -- Advanced Cooling Technologies, Inc. (ACT), a leading provider of thermal management solutions, announces a significant milestone in its global expansion.