Profusa Receives ISO Quality Certification in Berkeley

The Berkeley-based firm earned international quality standard certification for its Lumee Oxygen Sensor Platform manufacturing.

Updated on Oct. 15, 2026 in Healthcare

Profusa Receives ISO Quality Certification in Berkeley

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Profusa has been awarded the ISO 13485:2016 certification for the design, development, and production of its Lumee Oxygen Sensor Platform. The certification confirms that the quality management system at the company's Berkeley facility meets international standards.

Why it matters

This certification supports the company's ongoing efforts to achieve MDR conformity and CE marking. It is a critical milestone often required by hospitals and distributors during the procurement process in the European Union.

The ISO 13485:2016 certification confirms that the Berkeley facility's quality management system passed an independent audit against global medical device standards. This certification does not constitute formal FDA clearance or approval.

The players

Profusa

Profusa is a medical technology company that develops tissue-integrated sensors designed for continuous monitoring of body chemistry.

GMED

GMED is a notified body authorized to conduct audits and certify medical devices for compliance with European Union regulations.

The details

Issued by GMED, an EU MDR notified body, the certificate validates the processes used at the Berkeley site for the Lumee Oxygen Platform. Profusa is now leveraging this compliance as it continues working toward European commercial distribution.

February 2, 2026: FDA Quality Management System Regulation became effective.
September 24, 2026: Profusa announced a positive certification decision.
October 15, 2026: Profusa received the ISO 13485:2016 certificate.

Health Landscape

This achievement follows the recent effective date of the FDA's Quality Management System Regulation, which aligns domestic quality frameworks with the ISO 13485:2016 standard. Such certifications represent a critical step for manufacturers navigating the increasingly complex regulatory requirements of both U.S. and European medical markets.

While this certification does not change current patient access, it serves as a prerequisite for Profusa to bring its Lumee Oxygen Sensor Platform to new international markets. Patients can expect the company to move closer to official EU commercialization following this quality audit.

The takeaway

Achieving ISO 13485:2016 status is a standard benchmark that indicates a manufacturer has implemented rigorous internal quality controls. For firms aiming to scale operations, this certification is essential for meeting both regulatory demands and the expectations of international hospital buyers.