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
Profusa got an official stamp of approval from Europe for its oxygen sensor device. This means the company cleared a big hurdle to sell its product in Europe.
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