Medical Product Manufacturing and Assembly Services

From the initial concept to delivery of your finished products, DUKE Empirical partners with you every step of the way. Our engineering team can guide you through our design control process or we can support your internal product development process. When requested, our process begins with an understanding of your requirements and intended use as they are known at the time. From there we will create multiple design options, develop functional sample prototypes, test and compile data reports, and confirm that design outputs meet all requirements.  Upon prototype design freeze we will finalize the product specification, qualify and validate manufacturing processes for your custom medical products and components and certify conformance to dimensional and functional requirements. Let DUKE Empirical’s vast experience accelerate your product launch for your application specific technology.  Our mission is to provide manufactured products and services that consistently meet or exceed all defined requirements.
 

Proven Processes for Medical Device Manufacturing

In manufacturing customer-specified products, we use a wide range of validated production processes and equipment. Our dedicated manufacturing assembly processes takes place within ISO Class VIII certified controlled environment rooms. All manufacturing, assembly, and related services are performed in-house to ensure quality and consistency.
 
DUKE Empirical’s medical product manufacturing and assembly services include:
  • Design for Manufacturing
  • Pilot Manufacturing
  • Commercial Manufacturing
  • Quality
  • Automation Solutions
  • Assembly & Kitting
  • Packaging
  • Supply Chain Management
  • Sterilization
  • Regulatory Support
  • Logistics

Quality System for Early-Stage Catheter and Medical Tubing Product Manufacturing

Our quality system can facilitate the transfer of early-stage products into controlled manufacturing for pre-clinical product evaluation, physician preference testing, and clinical trials. We can transfer your designs from early-stage to commercial manufacturing, either as a component of a device which will undergo additional assemble at your facility, or as a complete product that is packaged, labeled, sterilized and ready for distribution.


Specialists in New Product Development for Catheter and Medical Tubing Products 

DUKE Empirical specializes in the development of new products according to customer needs. We are the industry’s fastest product development company, thanks to our broad in-house capabilities, all of which are centered around the development and manufacturing of catheter and medical tubing products. Our experience and expertise will help you take your new products through development and market launch in the shortest time possible.
 

The Medical Tubing Material Experts

At DUKE Empirical, we’re more than just medical device developers—we are also medical material experts! We have extensive process expertise working with medical grade polymers, biocompatible metals, and coatings for medical applications.
 
We have developed, and market a proprietary line of polymers and resins that have been tested to meet USP Class VI & ISO 10993 biocompatibility requirements and are engineered to provide unique advantages for medical products. These materials offer improved lubricity and higher performance for catheter and advanced medical technology products where strength, profile, flexibility, kink resistance, control, and deliverability are essential requirements.
 
Contact us to learn more about DUKE’s proprietary PebaSlix™, PolySlix™, NyloSlix™, and FluoroSlix™ materials. We offer the industry’s largest off-the-shelf inventory of tubing and related products, with immediate availability.
 

Contact Us for Complete Medical Device & Tubing Solutions

DUKE Empirical is the industry leading high-tech partner you need to accelerate your success in catheter and medical tubing projects. We deliver superior custom solutions to complex challenges, in the shortest time possible. Contact us or request a quote to get started on your project!
 
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