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

SUPPLIERS

The following list comprises our main partners/third parties. Qbtech shares data with them in order to perform our services. From time to time, we may update this list and you should check the list frequently for updates.

AMAZON WEB SERVICES

Server hosting since September 2016.
Amazon Web Services provides a highly reliable platform in the cloud that powers hundreds on thousands of businesses around the world.

BAHNHOF

Server hosting since May 2010.
Banhof AB is an Internet Service Provider that offers data transmission and broadband services.

BLUEPRINT.TV

Corporate site handling since November 2016.

BRAINTREE PAYMENTS

Payments solution services since April 2016.

GOOGLE

Analytics services. Qbtech supplier since December 2013.

VISMA ADMINISTRATION 

Invoicing services since April 2012

ZENDESK

Customer service solution. Qbtech supplier since November 2013.