In its letter to the European Commission, the European Organisation of Technical Assessment (EOTA) and stakeholders in the construction sector, the ERC advocates the adoption of CE marking through the ...
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 ...
(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 ...
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 ...
The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device manufacturer and its Dutch subsidiary over the ...
CE Marking enables marketing and clinical use of the world's first and only LINAC vault-ready proton therapy system across the European Union Mevion Medical Systems, the global leader in compact proto ...
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 commercializing ...
In January 2026, the ERC reaffirmed that CE marking via ETA should be the reference route for placing GFRP reinforcing bars on the European market. The objective is clear, remove technical barriers to ...
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