Quality – For us at Dynex Technologies, quality isn’t just a certificate on the wall; it is at the heart of everything we do. We ‘design in’ quality from initial product concept, through manufacture, delivery, and installation at the customer site. We know that customers count on our products as critical enabling tools for their important work. And our goal is to meet and exceed their expectations with the best, most cost-effective products and services available, delivered on time, and as promised.

Dynex is regulated by the United States Food and Drug Administration (FDA): when used for clinical applications, our instruments and accessories are Class 1 and Class 2 medical devices. Therefore, these products are designed and manufactured under the Medical Device Quality System Regulation, also known as Current Good Manufacturing Practices (cGMP), and are subject to periodic inspection by the FDA. Dynex adheres to US FDA 21CFR820. Systems used in conjunction with diagnostic kits require validation studies to assure proper assay performance.

Dynex has an ISO 9001:2000 certification. To view online copies of our Declarations of Conformity, click here. For more information about our quality policies, click here.