Medical Device Qualified Supplier Directory
Freudenberg Medical Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
Medical Device & Component Manufacturing
Catheters · Delivery Systems · Balloons · Hypotubes · Finished Devices
Components · Subassemblies · Molding · Extrusion · Coating
Freudenberg Medical is a global partner for the design, development and manufacture of innovative medical device technologies. With 11 manufacturing operations, Freudenberg Medical offers a wide range of capabilities from high precision silicone and thermoplastic molding and extrusion to coating technology, finished devices, and solutions for minimally invasive and catheter-based devices.
Freudenberg Medical operates FDA-registered medical device facilities, certified ISO 13485 with Class 7 & 8 cleanrooms. Manufacturing operations are located in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.
Medical Device Design and Development
Freudenberg Medical offers unparalleled expertise in the design, development, and manufacture of minimally invasive surgical and catheter-based devices. Our team uses a multi-phase design process to deliver the best products possible; this proven approach helps structure the flow of product development and ensures maximum collaboration at every step.
We co-develop breakthrough medical device designs using the latest design tools and techniques to create products that are robust, safe, effective, and within budget. We develop manufacturing processes that ensure effectiveness all the way through to product launch. We also validate processes across the spectrum of product development – from bottom-up creation to parallel line transfer.
Silicone Molding / Thermoplastic Molding
Molding capabilities include low- to high-volume injection molding, liquid injection molding (LIM), transfer/compression molding, micro-molding, insert molding, over-molding, and two-shot molding. Additional specialties include patented cold runner technology for silicone molding, advanced hot runner systems for both valve gate and open tip thermoplastics to reduce overall scrap, scientific injection molding, plus expertise in short- and long-term implantable LSR and HCR silicones.
Freudenberg Medical offers a wide range of value-added services from sterilization, assembly, and packaging to annealing, thermoforming, and pad printing.
Silicone &Thermoplastic Extrusion