Venture Capital Regulatory & Product Launch

KERANOVA receives the ISO EN 13485 certification

Friday 12 November, 2021

After building a first-class Quality Management System from the bottom up, Keranova has successfully received the ISO EN 13485 certification, for product design and development, at its first attempt by the GMED Notified Body. The company is entering the last phase that will lead to get market approval in 2022 for its revolutionary robotic FemtoMatrix® surgical system designed for automated photoemulsification of cataractous lenses.