Profusa Gains ISO Certification for Berkeley Facility
The certification allows the medical device maker to advance its planned expansion into European Union markets.
Updated on Oct. 15, 2026 in Healthcare
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Profusa has earned ISO 13485:2016 certification for its Berkeley, California, manufacturing facility. This milestone covers the development and production of the company's Lumee Oxygen Platform, marking a key step in its move toward European distribution.
Why it matters
Medical device manufacturers face rigorous quality management requirements to qualify for European hospital procurement. Securing this certification aligns Profusa's operations with international standards, facilitating the firm's planned expansion into European Union markets.
The ISO 13485:2016 certification is an international benchmark for medical device quality, now formally adopted by the FDA's Quality Management System Regulation. It is currently unclear when Profusa will receive the final CE marking required for full EU market access.
The players
Profusa
A medical device company that develops tissue-integrated sensing technologies for monitoring body chemistry.
GMED
A European Union notified body that provides independent testing and certification for medical device manufacturers.
The details
The certification process involved an independent audit of Profusa's quality systems at its Berkeley site to confirm conformity with international standards. While this certification does not grant FDA approval, it establishes a formal quality framework that satisfies international regulatory expectations. This infrastructure is a prerequisite for the company to complete ongoing MDR conformity assessments and successfully move toward European commercial distribution.
Timeline
February 2, 2026: FDA Quality Management System Regulation became effective.
September 24, 2026: Profusa announced the positive certification decision.
October 15, 2026: Profusa officially received the ISO 13485:2016 certificate.
Market Landscape
Medical device manufacturers must navigate the European Union Medical Device Regulation (MDR) to maintain or enter the European market. This certification signals that Profusa is following the standard industry path required to align its quality systems with these complex regulatory demands.
Medical device operators should view ISO 13485:2016 as a critical operational baseline for international market entry and distributor qualification. Firms must ensure their internal quality systems remain audited and current to meet evolving global regulatory requirements.
The takeaway
ISO certification serves as a fundamental signal to international distributors that a manufacturer has established formal control over its production processes. Operators should audit their own quality management systems against ISO 13485:2016 to ensure they are prepared for similar procurement qualification hurdles.
Further reading
For more on industry regulatory standards, visit the Healthcare section.
Source note: This article includes information reported by The Manila times.
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