Profusa Achieves ISO 13485 Certification for EU Market Entry
1 report, 1 independent
Updated Oct 15
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What happened
Profusa received ISO 13485 certification from GMED, an EU MDR notified body. This certification supports the ongoing conformity assessment activities for the Lumee Oxygen Platform and is a significant step toward CE marking. ISO 13485 is the internationally recognized standard for medical device quality management systems.
From manilatimes.net
Why it matters
The ISO 13485 certification is a core element of conformity assessment under the EU MDR. Achieving this standard permits Profusa to pursue commercial distribution in the European Union, subject to meeting applicable regulatory and operational requirements.
From manilatimes.net
Who's involved
- FDARegulatory agency whose authority is derived from the United States government.
- Center for Devices and Radiological HealthFormal division of the FDA that issues alerts and holds meetings.
- United States of AmericaGovernment whose regulatory agencies, like the FDA, derive their operational scope.
- Heidi OvertonAppointed to the formal leadership role of the FDA Commissioner.
- Donald TrumpUses executive authority to influence the FDA's regulatory operations and priorities.
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The entities involved
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