Regulatory

Commitment to Quality

As an integral aspect of our innovative and high integrity culture, Ziosoft designed, implemented and continues to nourish our Quality Management System in support of our vision to provide superior 3D 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 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
ISO 13485:2003 CMDCAS Quality Management System
ISO 13485:2003/ISO 9001 Quality Management System (Ziosoft Japan) Certificate #81 105 056529
US FDA Quality System Regulation (GMP) - The Company is compliant with 21CFR 820

Product Clearances, Registrations and Certifications

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
Am Grauen Stein 29
51105 Cologne, Germany
Tel: +49 180 311 2112
Website: http://www.tuv.com/de/en/medical_devices.html