A Few Words About Quality
Quality Systems, Regulatory Requirements, 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.
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
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.
Request Information or Support
If you would like to request information or a quotation for one of our products or have any questions, email us at info@intronixtech.com
If you need help with one of our products, or have any question when using one of our products, email us at support@intronixtech.com
Quality Certificates
U.S. Food and Drug Adminstration:
FDA (510(k) (Myoguide): K111985