The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...

In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union Batteries Regulation, which have applied since 18 August 2024.

Despite the fact that the CE mark has been around for more than 15 years, its meaning and importance are often not well understood by those who wish to market their products in Europe, as well as the ...

KANSAS CITY, Mo., March 1, 2011 (GLOBE NEWSWIRE) -- Cerner Corporation today announced that the CareAware iBus has received CE Marking certification from BSI on the basis of examination under Council ...

PARIS--(BUSINESS WIRE)--BrainTale, a French innovative company specialized in the development of software as a medical device for the quantitative measurement of the brain microstructure and the ...

IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of ...

SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Beam Global, (Nasdaq: BEEM), a leading provider of innovative and sustainable infrastructure solutions for the electrification of transportation and energy ...

MINNEAPOLIS, July 19, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, ...

SAINT-FERRÉOL-D'AUROURE, France, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Hexadrone SAS announces that it has obtained CE marking as well as C5 and C6 class certifications for its TUNDRA 2.1 drone. The ...

Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile diagnostic hub for the global market. LEHI ...