Profusa receives ISO 13485 certification from GMED
PFSA•Profusa received ISO 13485:2016 certification from GMED, enabling manufacturing of its Lumee Oxygen Platform; EU medical device conformity assessments are ongoing, with MDR certification and CE marking still pending.
1. Certification received
Profusa received ISO 13485:2016 certification from GMED, enabling manufacturing of its Lumee Oxygen Platform. Remaining EU medical device conformity assessments are ongoing, and MDR certification and CE marking are still pending.
