In our hands, your project is the definition of Turn-Key. DynaFlex has a proven solution to meet your custom needs as well as industry essentials such as prototyping for braided and coiled catheters, deflectable and steerable catheters, and micro-catheters. We pride ourselves on providing dedicated support during all stages of production and attributing special attention during the early development stage of the product’s life-cycle, from concept prototypes to full product builds for pre-clinical and clinical requirements.
In addition, recognizing that time to market is critical to the product’s success, we have dedicated engineers and equipment to ensure quality, timely, delivery of your prototype quantities of your product components and sub-assemblies. As an example, our standard medical device catheter shaft prototypes in low-volume typically have a 1-2 week lead time depending on design requisite.
Our competence is such that we are fully capable and set up to prepare your product for commercial release and build your complete device requirements, in volume, from complete finished and packaged products to sub-assemblies and components. Our ISO Class 7 (class 10,000) Controlled Environment is continuously monitored and maintained to ensure that we meet and/or exceed required levels of cleanliness. Our processes are strictly documented, monitored, and controlled so as to assure conformance and traceability of all products and materials.
We offer specialized services for turn-key manufacturing that include the following infrastructure and solutions:
Catheter Laminator, Layup, Reflow, Shaping, Tipping, and Tight Tolerances Cutting
NiTi Heat Setting
Catheter Braiding and Coil Winding
Latest Sla 3-D Printing
Mechanical and Electrical Testing
Engineering Supported Prototyping
Volume Manufacturing Line Development
Lean Manufacturing Programs
Extensive Tooling Capability
Latest catheter manufacturing equipment from leading manufactures including Machine Solutions, Beahm, Steeger, Roth Greaves, Arbug, Mellen, OGP, Conair, Zeiss, and Mitutoyo.