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Legal

Last updated on: 07/02/2023

Quality Management System

US FDA (21 CR Part 820) compliance

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

ISO 27001

Certificate of Registration of Information Security Management System to ISO 27001:2013

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ISO 13485:2016

Certificate of Registration of Quality Management System to I.S. EN ISO 13485:2016

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Product Certifications and Approvals

Australia- Devices listed in ARTG

View the Public ARTG summary

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Europe - CE Marking certificates

View the Certificate of Registration issued by the Medical Products Agency

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United States - FDA 510(k) cleared/PMA approved devices

View our Establishment Registration on the FDA website

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United States - FDA 510(k) cleared/PMA approved devices

QbTest - assessment of ADHD in children

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United States - FDA 510(k) cleared/PMA approved devices

QbTest - assessment of ADHD in adolescents and adults

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United States - FDA 510(k) cleared/PMA approved devices

QbTest - treatment follow up in children, adolescents and adults

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United States - FDA 510(k) cleared/PMA approved devices

QbCheck- assessment and treatment of ADHD in children, adolescents and adults

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ICO Registration Certificate

View our Registration Certificate from the Information Commissioner's Office (ICO)

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Global Regulatory Representatives

ICO Registration Certificate

Australia - Sponsor
EMERGO AUSTRALIA,
Sydney,
Australia
Telephone: +61 2 9006 1662
Website: www.emergogroup.com

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Europe

Qbtech AB,
Cardellgatan 1,
11436 Stockholm
Sweden
Telephone: +46 8 790 50 01
Website: www.qbtech.com

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United States - Agent

Emergo Group Inc.,
Austin,
Texas
USA
Telephone: +1 512 327 9997
Website: www.emergogroup.com

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Data Sub-processors

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

Bahnhof AB is an Internet Service Provider that offers data transmission and broadband services.

Braintree Payments

Payments solution services since April 2016

Google

Analytics services. Qbtech supplier since December 2013

Fortnox

Invoicing services since December 2019

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Zendesk

Customer service solution. Qbtech supplier since November 2013

Microsoft

Cloud Infrastructure for our products and services

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