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/IEC 27001:2022, 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.
Quality Management System ISO 13485:2016
& EN ISO 13485:2016
Click to view certificate MD 726973
Click to view certificate ISO 13485
By country
Australian Therapeutic Goods Administration (TGA)
ProEX and ProEX Mobile ARTG number 305324
GEIS® ARTG number 283581
For all Visionflex ARTG entries click here
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 (EU)
Follows the provisions of the MDR 2017/745
