Median Technologies Secures Key Certification for its AI Oncology Software
Median Technologies announces the acquisition of the international ISO 13485:2016 certification for its Quality Management System applicable to medical device software based on artificial intelligence. This certification, issued by the accredited notified body GMED, covers all activities of the eyonis® operational unit.
Validation of Industrialization and Large-Scale Deployment
The ISO 13485:2016 certification validates Median Technologies' ability to industrialize and deploy on a large scale its eyonis® portfolio, including the design, development, deployment, sales, and maintenance of AI-based medical device software. This certification is part of a compliance cycle initiated in 2025, which has already resulted in the acquisition of ISO 27001:2022 and HDS 2.0 certifications. These certifications demonstrate the robustness and high quality of the company's quality management system, as well as its ability to handle sensitive data.
A Major Step Towards Future Regulatory Approvals
Median Technologies describes this certification as major in view of future regulatory approvals for its eyonis® portfolio, particularly the expected CE marking in the second quarter of 2026 for eyonis® LCS. The company emphasizes that this certification strengthens its preparation and ability to provide safe, reliable, and clinically relevant oncology solutions, meeting the stringent requirements of healthcare professionals and international regulatory authorities. This validation follows the FDA's 510(k) authorization for eyonis® LCS in February 2026 and the commercial launch in the United States.
