Median Technologies’ eyonis QMS Earns ISO 13485:2016 Certification

Median Technologies has achieved ISO 13485:2016 certification for its Quality Management System (QMS) applicable to artificial intelligence (AI)-based Software as Medical Devices (SaMD).

The ISO 13485:2016 certification, granted by the French accredited notified body GMED, encompasses the full scope of activities of Median’s eyonis business unit, including the design, development, deployment, sales and maintenance of AI-based SaMD. This certification confirms the company’s ability to industrialize and scale eyonis, its advanced SaMD portfolio, in accordance with the latest regulatory requirements. eyonis is a suite of AI-powered SaMD solutions for early cancer diagnosis.

“2026, which is set to be a pivotal year for Median Technologies and builds on the FDA 510(k) clearance and commercial launch of eyonis LCS, continues on a positive trajectory with the achievement of ISO 13485:2016 certification, which validates the strict quality framework supporting eyonis, our AI‑based SaMD portfolio”, Median Technologies Founder/CEO Fredrik Brag said. “This certification marks a key milestone while strengthening our readiness for future regulatory authorizations for the eyonis portfolio of solutions, including the expected CE marking of eyonis LCS. It further underscores our ability to deliver safe, reliable, and clinically meaningful oncology solutions that meet the stringent requirements of healthcare professionals and regulatory authorities worldwide.”

The Company’s ISO 13485:2016 certification adds to the compliance cycle started with the ISO 27001:2022 and HDS 2.0 certifications obtained last year.

Pioneering software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis, an AI/ML tech-based SaMD suite. The French-based company, with a presence in the United States and China, trades on the Euronext Growth market. Median is also eligible for the French SME equity savings plan scheme (PEA-PME).