The Company’s designated Notified Body confirmed dates for conducting audits for ISO 13485 certification to ensure Microbot complies with the QMS requirements of the EU MDR The Company expects that ...

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 ...

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 ...

(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.

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 ...

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 ...

GenesisX was approved in Europe and is set to be approved in the US late this year. The new robot is a giant leap forward in accessibility. Stereotaxis should get MAGiC approved in Europe in October.

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on ...