Providing a Foundational Quality Management System (QMS) for Commercialization
- Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announced
- ISO 13485 certification supports ongoing MDR conformity assessment activities for the Lumee Oxygen Platform and represents an important milestone toward MDR certification and CE marking.
BERKELEY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (NASDAQ:PFSA) ("Profusa" or the "Company"), a digital health company pioneering next-generation biosensor technologies, today announced that it has received its ISO 13485:2016 certificate from GMED, a notified body designated under the European Union Medical Device Regulation (MDR). The certificate covers the design, development and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers (the Lumee Oxygen Platform) at the Company's Berkeley, California facility. Its issuance follows the positive certification decision Profusa announced on September 24, 2026.
ISO 13485 is the internationally recognized standard for medical device quality management systems. Certification demonstrates, through independent audit, that Profusa's quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification. ISO 13485:2016 certification is a significant step supporting the Company's ongoing MDR conformity assessment activities for the Lumee Oxygen Platform. ISO 13485 certification is also commonly expected of medical device suppliers during European hospital procurement and distributor qualification processes. CE marking would indicate conformity with applicable EU MDR requirements and permits the Company to pursue commercial distribution in the European Union, subject to satisfying applicable regulatory and operational requirements.