Regulatory compliance

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.

Quality Management System ISO 13485:2016 & EN ISO 13485:2016


HIPAA Seal of Compliance

HIPAA Seal of Compliance

Therapeutic Goods Administration

Australia Flag

ProEX and ProEX Mobile ARTG number 305324

GEIS ARTG number 283581

For all Visionflex ARTG entries click here

U.S. Food & Drug Administration

United States flag

ProEX and ProEX Mobile listing number D298044

GEIS listing number D299774

For all Visionflex listings please click here

European Union

European Union flag

Follows the provisions of the MDR 2017/745