Quality Systems, Regulatory Compliance, and Certificates

Our quality system is registered to ISO 13485:2016 MDSAP. BSI is our quality systems registrar.  We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. Emergo Group is our US FDA agent.

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Our Policy Statement

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


Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997

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