DUKE Empirical is committed to providing contract manufacturing and engineering for the medical device industry, that meet or exceed all defined customer requirements, regulatory requirements, and to maintaining an effective quality management system (QMS). DUKE Empirical maintains an EN1345:2016 compliant quality system. This quality system has been independently certified since 2003. The DUKE Empirical quality system defines the methods for performing each process associated with your product 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

Process Qualification:

DUKE Empirical will guide design projects through four defined phases of development:

  • Definition
  • Design and process development
  • Qualification
  • Production/build for launch

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