Commitment to Quality


As an integral aspect of our innovative and high integrity culture, Ziosoft (Qi Imaging) designed, implemented and continues to nourish our Quality Management System in support of our vision to provide superior advanced imaging software tools to meet the broadest range of both current and future customer needs. To realize our commitment to provide these increasingly useful tools to the international medical community, Ziosoft (Qi Imaging) developed this Quality Management System to be in full compliance with the regulatory requirements of the various markets in which we are active.

Quality Management System Compliance
ISO 13485:2003 + AC 2007 Quality Management System
US FDA Quality System Regulation (GMP) - The Company is compliant with 21CFR 820

Product Clearances, Registrations and Certifications
US FDA 510(k) Clearances
European CE Mark (MDD 93/42/EEC)
Japan MHLW approval #21600BZZ00358000

Global Regulatory Representatives
EUROPE - Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH, The Hague, Netherlands
Tel: +31 70 345 8570
Website: http://www.emergogroup.com

Notified Body / Registrar / Certification Body
TÜV Rheinland LGA Products GmbH
Tillystrasse 2
0431 Nureberg, Germany
Tel: +49 911 655 5225
Website: http://www.tuv.com/en/corporate/business_customers/product_testing_3/medical_devices_engineering_1/medical_products.html