Custom Medical Catheter & Medical Device Tubing Manufacturing Services
DUKE Empirical is a leading contract manufacturer of finished medical devices, specializing in catheter-based medical devices, delivery systems, custom medical tubing, and related minimally invasive surgical products.Customers rely on us for complete product development and fulfillment services. We work with our customers’ resources and cross-functional teams to launch products in the shortest time possible.
Custom Medical Device Manufacturing Bringing Innovation to Life™
DUKE Empirical has over 18 years of experience assisting clients with launching and manufacturing new medical products. As a full-service manufacturer, DUKE Empirical supports the entire product life cycle from the initial design, engineering, testing and development through full-scale validated manufacturing and regulatory compliance. Our manufactured products are certified according to an EN 13485 compliant quality system assuring compliance with the latest regulatory requirements. DUKE Empirical’s integrated device manufacturing capabilities provide our clients the fastest path to market by shortening the supply chain for complex medical devices.Request For Quote
Full-Service Catheter & Medical Device Contact Manufacturer
Full-Service Catheter & Medical Device Contact Manufacturer
DUKE Empirical manufactures products for original equipment manufacturers (OEMs) marketed for our clients throughout the world. Our product designs feature the latest material advancements, including our brand of proprietary materials, which add differentiating features to your product, enabling a competitive advantage over alternative offerings.Custom Automated Manufacturing Equipment
In addition to customized materials, DUKE Empirical develops and utilizes custom automated manufacturing equipment for the precision and processing controls necessary for manufacturing next-generation medical technologies where thinner and smaller product profiles are combined with new product performance features.
Customized Materials, Designs, and Features for your Medical Tubing Needs
Customized Materials, Designs, and Features for your Medical Tubing Needs
DUKE Empirical provides customized features such as energy delivery, sensing and data acquisition, multi-plane articulation, dynamic positioning location, optical, and other imaging modalities to your custom manufactured medical tubing. Our team of experts utilizes the latest materials, designs, and manufacturing processes to produce the most innovative, high-quality, performance catheter systems and medical tubing for world-leading OEMs.ISO Class 8 Cleanrooms
DUKE Empirical utilizes ISO Class 8 cleanrooms to extrude, manufacture, and assemble our medical tubing, catheter components, and finished goods. Our controlled environment rooms are monitored for particulate to the ISO 14644 standards. In addition to meeting the ISO standard for particulate, the rooms are monitored for microbiology, making them suitable for medical device manufacturing.Turnkey Design & Contract Manufacturing for New & Existing Medical Tubing Products
We offer complete, turnkey design and manufacturing for both new and existing product designs. Our services include:
- Product design, development, and testing
- Prototyping and concept development
- Component level sub-assemblies
- Design control process
- Design verification and validation
- Simulated use testing
- EN 13485 Certified Quality System compliance
- Lean manufacturing
- Product sterilization
- Biocompatibility testing and validation
- Lot release testing
- Regulatory planning and compliance
- DFM (design for manufacturing)
- Process qualification and validation
- Design of experiments
- Packaging design and validation
- Supply chain management
- Fulfillment and more
