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 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

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ProEX and ProEX Mobile ARTG number 305324

GEIS ARTG number 283581

For all Visionflex ARTG entries click here


U.S. Food & Drug Administration

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ProEX and ProEX Mobile listing number D298044

GEIS listing number D299774

For all Visionflex listings please click here



European Union

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Follows the provisions of the MDR 2017/745