SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...

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 ...

GREEN BAY, Wis.--(BUSINESS WIRE)--Pioneer Metal Finishing, LLC ("Pioneer"), is pleased to announce the ISO 13485 certification of its Medical Center of Excellence facility in South Bend, IN. “This ...

Teltonika’s TeltoHeart, a multifunctional smart wristband system developed in cooperation between Lithuanian industry and universities has been given the CE MDR (Class IIa) medical device ...

ReShape Lifesciences has achieved EU MDR and UKCA certifications for its medical devices, enhancing market access and ensuring safety compliance. ReShape Lifesciences announced that its Quality ...

The European Medicines Agency (EMA) is looking for IT security experts who can help ensure its data are safe and properly managed. Officials hope to create a list of experts they can turn to for ...

Malaysia’s Medical Device Authority (MDA) is seeking feedback on proposed changes to its guidance on the application requirements for certain certificates. MDA is planning to expand the guidance ...