DUKE Empirical is committed to providing contract manufacturing and engineering for the medical extrusion industry, that meet or exceed all defined customer requirements, regulatory requirements, and to maintaining an effective quality management system (QMS). Duke Empirical maintains an ISO 13485:2003 compliant quality system. This quality system has been independently certified by DEKRA since March 2003. The DUKE Empirical quality system defines the methods for performing each process performed in association with your product including:

Process Qualification:

When our customer’s needs dictate, DUKE Empirical will guide their design projects through four defined phases of development:

DUKE Empirical maintains controlled copies of our customer's specifications for each product manufactured at DUKE Empirical. DUKE Empirical will not make changes to products or processes that affect defined specifications without formal written approval from our customer.

DUKE Empirical proudly welcomes our customers to perform on-site audits and inspections of our facility and quality system. We will provide copies of our Quality Manual and relevant Standard Operating Procedures to our customers upon requests.