Quality Certifications & Quality Control
DUKE Empirical is committed to providing contract manufacturing and engineering 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 Empirical 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
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 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. Contact DUKE Empirical to learn more.
