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 have received the HIPAA Seal of Compliance and 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.
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
Follows the provisions of the MDR 2017/745