Median Technologies Secures ISO 13485:2016 Certification for eyonis® QMS
Event summary
- Median Technologies achieved ISO 13485:2016 certification for its eyonis® Quality Management System (QMS) on March 18, 2026.
- The certification, granted by GMED, covers the full scope of eyonis® activities, including design, development, and maintenance of AI-based Software as Medical Devices (SaMD).
- This follows the FDA 510(k) clearance and commercial launch of eyonis® LCS in early 2026.
- Median expects CE marking for eyonis® LCS in Q2 2026.
The big picture
Median Technologies’ ISO 13485:2016 certification underscores its commitment to stringent quality standards in AI-powered medical devices, aligning with broader industry trends toward regulatory rigor in SaMD. This certification complements previous ISO 27001:2022 and HDS 2.0 certifications, reinforcing Median’s position as a leader in AI-driven oncology solutions. The certification is particularly strategic as it follows the FDA 510(k) clearance for eyonis® LCS, positioning the company for further regulatory milestones in 2026.
What we're watching
- Regulatory Momentum
- Whether the ISO 13485:2016 certification will accelerate the global approval process for eyonis® solutions.
- Market Expansion
- The pace at which Median can scale eyonis® in key markets following this certification.
- Competitive Positioning
- How this certification strengthens Median’s standing against competitors in the AI-powered oncology diagnostics space.
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