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RetinaLyze System receives ISO 13485:2016 certification

RetinaLyze System's quality management system has been independently audited to be compliant with ISO 13485:2016.

Posted on
June 3, 2022
in
Company news

We, at RetinaLyze System, have always had security and safety as our primary focus in our work with medical devices.

Therefore, we have adhered to internal processes governing how our development & operation of services as well as cooperation with other companies should be documented and risk mitigated. Such internal process are referred to as being part of a quality management system.

Our quality management system has now been independently audited and we are proud to have received an ISO 13485:2016 certification.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Read more here: https://www.iso.org/standard/59752.html

Ganesh Ram

CCO and Co-founder of @RetinaLyze.
Productivity and UX-geek.
Passionate about making an impact.