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.

Visionflex is certified to ISO 13485 Medical Devices – Quality Management Systems in addition to the MDSAP -Medical Device Single Audit Programme. Visionflex also maintains the HIPAA Seal of Compliance.

Visionflex devices have been approved by the Australian Therapeutic Goods Administration as well as multiple international regulatory bodies.

BSI logo
Medical Device Single Audit Program

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

Click to view certificate MD 726973
Click to view certificate ISO 13485

HIPAA Seal of Compliance

HIPAA Seal of Compliance

Click to view certificate

By country

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Australian Therapeutic Goods Administration (TGA)

ProEX and ProEX Mobile ARTG number 305324
GEIS® ARTG number 283581
For all Visionflex ARTG entries click here

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U.S. Food & Drug Administration (FDA)

ProEX and ProEX Mobile listing number D298044
GEIS® ARTG number D299774
For all Visionflex listings please click here

European Union flag

European Union (EU)

Follows the provisions of the MDR 2017/745