DUKE Extrusion is a division of DUKE Empirical, Inc.
DUKE Emprical is committed to providing superior quality tubing and extrusions for the medical device industry. We maintain an effective quality management system (QMS) to create products that meet or exceed all defined customer requirements and regulatory specifications.
Our ISO 13485:2003 compliant quality system has been independently certified since 2003. The DUKE Empirical quality system defines the production methods associated with manufacturing our customers’ products, including:
Receipt and inspection of materials
Non-conforming material review and disposition
Supplier and purchasing controls
Corrective and preventative actions
Calibration and preventative maintenance of equipment
Quality assurance seal for contract engineering and manufacturing services for the medical device industry.
When the customer’s needs dictate, DUKE Empirical will guide new product introduction projects through four defined phases of development:
Design & Process Development
Production/Build for Launch
DUKE Empirical maintains controlled copies of our customers’ specifications for each product we manufacture. We do not make changes to products or processes that affect defined specifications without formal written approval from the customer.
We welcome our customers to perform on-site audits and inspections of our facility and quality system. We will provide copies of our Quality Manual to our customers upon request.