TEAM Technologies recently acquired Duke Empirical with over 18 years of experience in the catheter and device market. We specialize in providing catheter manufacturing solutions for all of your application challenges. When you work with us over other catheter manufacturing companies, in addition to our superior materials, you will receive:
- Fastest Industrial Lead Time
- Dedicated Engineering & Development Resources
- Superior Customer Service
- Production within ISO Class VIII CER & ISO 13485:2016 Certified Quality & Management Systems
- Production within ISO 13485:2016 Regulations
Full Catheter Production
Our in-depth expertise specializes in the design of catheter-based minimally invasive surgical and medical tubing products across a wide range of clinical market segments. Our TEAM of product development engineers utilizes the latest material technology and processing equipment to produce the highest-performing catheter and medical tubing products which are specifically designed to enable new medical procedures.
Our development service options include:
- FMEA (failure mode effects analysis)
- Risk Assessment
- Functional Test Plan creation
- Testing Protocol Development
- Design, fabrication, and implementation of testing fixtures
- Test Method Validation
- Supporting Regulatory Filings with Design History File Records
Custom Catheter Designs for the Medical Market
For clients with unique product challenges, our experienced team can provide high-quality medical design solutions. TEAM Technologies | DUKE Empirical assists clients with the preliminary design specification and provides guidance for informed specification development based on our substantial product development and manufacturing experience, both at the concept phase and also the design screening phase.
Private Label Medical Catheter & Device Manufacturer
If you’re a medical OEM looking for a medical catheter manufacturer and medical device manufacturer to create high-quality, customized private label catheter products, using TEAM Technologies | DUKE Empirical catheter components provides the fastest way to market your new catheter-based medical technology.
As an industry leader in the development of novel access catheters as well as therapeutic, diagnostic, and implantable device delivery systems. Our OEM private label catheter components are designed with cost-effective, innovative materials that reduce friction while offering reusability in certain products.
We Now Offer VERGO® Steerable Access Sheaths
VERGO® is our newest private label product in the TEAM Technologies | DUKE Empirical line. Learn more about our VERGO® Steerable Access Sheaths.
Catheter Device Design Verification
TEAM Technologies | DUKE Empirical provides design verification for new products according to ISO 13485:2016 compliant design control standards to confirm that the design meets all of the defined requirements for the intended use.
The design verification process confirms that the design input, which is provided by the customer, meets the design output, which is confirmed by empirical methods. The medical design and manufacturing process follows a phased approach.
Medical Manufacturing and Assembly Services
We partner with you every step of the way of your design and manufacturing process.
- Design for Manufacturability (DFM)
- Pilot Production
- Commercial Manufacturing
- Quality
- Automation Solutions
- Assembly & Kitting
- Packaging
- Supply Chain Management
- Sterilization
- Regulatory Support
- Logistics
Custom Catheter Medical Device Manufacturing Technologies Options
At DUKE Empirical, our mission is to deliver the best custom in-house medical extrusion technologies in the industry for your custom catheter extrusion needs. We accomplish this through custom design, development, and manufacturing processes that meet your exact project specifications. DUKE offers the following custom in-house catheter-based medical device technologies:
Visit TEAM Technologies | DUKE Empirical – https://www.dukeempirical.com/ to discover more.
Contact us for more information on how we can help with your advanced sewing requirements.
