Quality Assurance

The Luminex Corporation’s sites for in vitro diagnostic (IVD) products have had their Quality Management Systems (QMS) certified to the ISO 13485:2016 standard, which is an internationally recognized standard for quality management systems for medical devices.

The certified sites are Luminex Austin, Madison, Toronto and Chicago.

Luminex Austin, Madison and Toronto site QMS are also certified 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/

Recently, Luminex has achieved multi-site certification where Luminex Austin, Madison and Toronto QMS are certified under a single shared ISO and MDSAP certificate.

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 support@luminexcorp.com 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.

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