Median Technologies’ eyonis QMS Earns ISO 13485:2016 Certification

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Summary

Median Technologies has earned ISO 13485:2016 certification for the quality management system supporting its eyonis AI-based software as a medical device portfolio. The certification covers the design, development, deployment, sales, and maintenance of the company’s SaMD activities. It strengthens the company’s ability to scale eyonis in line with current regulatory requirements and supports future authorizations, including expected CE marking for eyonis LCS. The announcement also builds on the company’s earlier ISO 27001:2022 and HDS 2.0 certifications.

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HealthTech
applications
AI & Machine learning

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Healthcare Software Medical Imaging Software Artificial Intelligence Software

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Median Technologies
$10M to $25M