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 ...

Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has ...

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 ...