ISO 13486:2016 Certified, FDA Approved
As an ISO 13486 certified and US FDA approved manufacturer we offer our OEM clients detailed input and risk analysis processes and procedures focusing on end user requirement, patient safety and patient satisfaction.
Our state of the art manufacturing processes include the following OEM services:
Research and Development
An experienced team of engineers and medical doctors will work together to achieve best quality and device functionality within mutually agreed time lines and according to stat-of-the-art industry standards. We aim generate competitive advantage for our OEM clients.
Manufacturing tools and production devices
Since time-to-market is crucial, we will design and manufacture production tools, molds and even adjustable functions machines.
Our state-of-the-art facility allows manufacturing our tubes in different profiles and sizes using a wide range of thermoplastic materials. Our professional extrusion engineers work closely with our R&D through all stages of prototype design and development, applying suitable materials and manufacturing processes.
We have a unique process for tube fusion which adds great value to the prototyping and production processes.
Overmolding, as an injection molding process, has evolved along with material advances over the past decade and has led to new technical and creative opportunities for medical device applications. Beyond soft touch, the process offers numerous possibilities for designing parts with improved aesthetics, added functionality, brand identification, and increased value.
Over molding, a multi-material process enables device OEMs to take economical advantage of two or more materials with different properties by incorporating them into one molded component. Our understanding of polymer behavior, advanced machinery, and our commitment to high quality, produces most accurate results.
Our proprietary induction heat formers can be used for producing a broad range of catheter tips with open, closed, and soft ends. These custom-built induction tip forming systems can handle catheter tubes with outer diameters as small as 0.025" and as large as 0.263".
Most conventional thermoplastic polymers can be formed. Manufacturing flash-less dies and mandrels for custom tip forming operations is our specialty. Purpose-designed forming tools contour the OD and tip of the tubing while maintaining a clean through-hole. Depending on the type of polymer used and tube size.
Our service includes catheter assembly, welding, fusion, heat forming, curving, drilling, skiving, and pad printing.
Catheters products to other companies in several forms.
The catheters can be supplied in bulk, as sterile, non-sterile, finished or semi-finished products and the designs can be customized based on customers' needs.
Contract Manufacturing (CMO)
Amecath is a global supplier offering support to companies worldwide with the development and manufacturing of catheters , including Dialysis Catheters, Central Venous Catheters and Urology Catheters.
We are the right Contract Manufacturing Organization to address your needs. Contact us to discuss how we can match your manufacturing needs.
Leverage our experience from being the long-standing Contract Manufacturing Organization of Terumo/Belgium for its complete range of the Central Venous Catheters & Kits.