Profusa Receives ISO 13485:2016 Certificate from GMED

Profusa received its ISO 13485:2016 certificate from GMED, an EU MDR notified body, covering the design, development and manufacture of the Lumee Oxygen Platform at its Berkeley, California facility. The certification supports ongoing MDR conformity assessment toward a potential MDR certificate and CE marking, and enables Profusa to begin manufacturing the Lumee Oxygen Sensor Platform.

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