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.
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 ...
The European Union (EU) has adopted three new regulations that aim to modernize the “New Approach” or NRF (New Regulatory Framework) for EU directives. These regulations were adopted in 2008, and the ...
HUNTINGTON BEACH, Calif., Dec. 15, 2010 (GLOBE NEWSWIRE) -- iTech Medical, Inc. (OTCBB:IMSU) (Frankfurt:0IM), a medical information technology company, announced today that it has received CE Mark ...
PARIS, July 28, 2025--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic ...
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.
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve ...
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.