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QUALITY ASSURANCE

Quality Assurance

Luminex is committed to providing quality products to our customers

Luminex has certified our Quality Management System (QMS) to the ISO 13485:2016 standard, which is an internationally recognized standard for quality management systems for medical devices.

 

Luminex has also certified our Quality Management System (QMS) to meet the requirements of the Medical Device Single Audit Program (MDSAP). The MDSAP certificate provides evidence of compliance to the regulatory requirements of the following countries: Australia, Brazil, Canada, Japan and the United States of America.

 

For more information on MDSAP, click on the link below:
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/

 

Luminex is committed to providing quality products to our customers and meeting your expectations. If you are not completely satisfied with our products or processes, please contact us at [email protected] or 1-877-785-2323 (Domestic), +512-381-4397 (International). We also welcome your suggestions and comments about possible product enhancements or new product ideas.


LUMINEX, AUSTIN

EN ISO 13485:2016 Certificate
MDSAP Certificate

LUMINEX, TORONTO

EN ISO 13485:2016 Certificate
MDSAP Certificate

LUMINEX, MADISON

EN ISO 13485:2012 Certificate
ISO 13485:2003 CMDCAS Certificate