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Profusa Secures Its ISO 13485:2016 Certificate From EU MDR Notified Body, GMED, Covering Lumee Oxygen Platform
Providing a Foundational Quality Management System (QMS) for CommercializationCertificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announcedISO 13485
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Profusa shares are trading higher after the company announced it received a positive decision from GMED regarding certification of its quality management system to ISO 13485.
Profusa Says It Received Positive Quality System Certification Decision From EU Certifier GMED; Lumee CE Mark Still Pending