Quality Certifications & Quality Control

Duke Extrusion is a division of Duke Empirical, Inc.

Duke Extrusion is committed to providing superior quality medical 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 13485:2016 compliant quality system has been independently certified since 2003. The Duke Extrusion quality system defines the production methods associated with manufacturing our customers’ products, including:

  • Contract review
  • Receipt and inspection of materials
  • Non-conforming material review and disposition
  • Supplier and purchasing controls
  • Process controls
  • Corrective and preventative actions
  • Calibration and preventative maintenance of equipment

Certified by DEKRA 

DEKRA Seal

Quality assurance seal for contract engineering and manufacturing services for the medical device industry.

Process Qualifications

When the customer’s needs dictate, Duke Empirical will guide new product introduction projects through four defined phases of development:

  • Definition
  • Design & Process Development
  • Qualification/Validation
  • Production/Build for Launch

Duke Extrusion 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. Contact Duke Extrusion to learn more.

 
 
 
 
 
Duke Extrusion Duke Extrusion

Duke Extrusion is a division of Duke Empirical, Inc., a contract manufacturer and developer of innovative medical devices.