QUALITY MANAGEMENT SYSTEM

US FDA (21 CR Part 820) compliance

We are fully compliant with the US FDA Quality System Regulation.

PRODUCT CERTIFICATIONS AND APPROVALS

AUSTRALIA - Devices listed in ARTG

View the Public ARTG summary on the TGA website

EUROPE - CE Marking certificates

View the Certificate of Registration issued by the Medical Products Agency

UNITED STATES - FDA 510(k) cleared/PMA approved devices

View our Establishment Registration on the FDA website
QbTest - assessment of ADHD in children
QbTest - assessment of ADHD in adolescents and adults
QbTest - treatment follow up in children, adolescents and adults
QbCheck - assessment and treatment follow up in children, adolescents and adults

GLOBAL REGULATORY REPRESENTATIVES

AUSTRALIA - Sponsor

EMERGO AUSTRALIA, Sydney, Australia
Telephone: +61 2 9006 1662
https://www.emergogroup.com/services/australia/australia-tga-sponsor

EUROPE

Qbtech AB, Kungsgatan 29, SE-111 56 Stockholm, Sweden
Telephone: +46 8 790 50 01 

https://www.qbtech.com/

UNITED STATES - US Agent

Emergo Group, Inc., Austin, Texas USA
Telephone: +1 512 327 9997

https://www.emergogroup.com/services/united-states/us-fda-agent