Complying with essential requirements can be a daunting task for device manufacturers. After all, if a device manufacturer wants to introduce a medical device in the European Union (EU), it should be ...

Profusa received a positive decision from GMED on ISO 13485 certification, expected in early October, while additional European MDR conformity assessment work remains before the Lumee Oxygen Platform ...

Suprema announced that its AI-based facial authentication access control devices have obtained CE RED certification under the European Union (EU)’s updated Radio Equipment Directive (RED), which now ...

MIAMI, July 28, 2026--(BUSINESS WIRE)--OpenEvidence, the leading AI-powered medical search and decision support platform, has launched a new education platform offering accredited, interprofessional ...