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 ...

The European breast implant recall raises questions about the effectiveness of the European Union’s CE Mark medical device approval process say critics of the process, according to a MassDevice report ...

(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 ...

CMR Surgical announced today that it received CE mark and UK approval for its Versius surgical robot in pediatric surgery.

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 ...