Profusa wins positive GMED decision on ISO 13485 quality system certification
PFSA•Profusa received a positive GMED decision on ISO 13485 certification for its quality management system, with certification expected in early October as part of the Lumee Oxygen Platform CE mark process under the EU MDR.
1. Certification process
Profusa received a positive decision from GMED on ISO 13485 certification for its quality management system. Certification is expected in early October as part of the Lumee Oxygen Platform CE mark process under the EU MDR, though remaining GMED conformity assessment steps could affect the timing of the MDR certificate and CE marking.
