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