Visionflex is committed to designing industry-leading medical devices that are effective, elegant, easy to use, and conform to the most stringent customer and regulatory requirements. We proudly maintain a certified ISO 13485 Quality Management System through a systemic approach to risk. Our devices have been approved by the Australian Therapeutic Goods Administration as well as multiple international agencies.
Quality Management System ISO 13485:2016 & EN ISO 13485:2016
Therapeutic Goods Administration
ProEX and ProEX Mobile ARTG number 305324
GEIS ARTG number 283581
U.S. Food & Drug Administration
ProEX and ProEX Mobile listing number D298044
GEIS listing number D299774
European Union
Follows the provisions of the MDR 2017/745