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

“The EU applies the CE Marking process primarily to ensure safety, as well as a reinforced manufacturer obligation with respect to device claims. The FDA does this too, but has the additional ...

MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: Today marks World Tuberculosis (TB) Day and bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces the CE ...

SALT LAKE CITY--(BUSINESS WIRE)--Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced ...

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.

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

BBS Bioactive Bone Substitutes Oyj ‘s Notified body BSI has become to the conclusion that the provided clinical data is insufficient as required by the new MDR and as a result they will proceed ...