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Quality Systems, Regulatory Compliance, and Certificates

Our quality system is registered to both ISO 9001:2008 and ISO 13485:2003. BSI is our quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment System (CMDCAS). Intronix is also monitored by TüV for safety testing and production monitoring. We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. Emergo Group is our European Authorized Representative for global-in-country representation, and our US FDA agent.

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Our Policy Statement

We at Intronix Technologies Corporation are committed to delivering fault-free products on time, complying with requirements, continually improving the effectiveness of our Quality Management System and satisfying our customers’ needs.

USA FDA Agent

Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
http://www.EmergoGroup.com/services/us

EUROPE – Authorized Representative

Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570
http://www.EmergoGroup.com/services/europe

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