Why Plastics and Composites for the Medical Industry?
Plastics and composites offer significant advantages in the most challenging medical industry applications over traditional materials like aluminum, titanium and other metals. Plastics and composites are available in medical grade formulations, some of which are FDA, USP Class VI, and ISO 10993 compliant. These materials offer enhanced chemical resistance, ability to handle repeated sterilization / steam autoclave cycles, ethylene oxide gas (EtO) sterilization, gamma sterilization, low friction, excellent wear resistance, biocompatibility, medical grade colors, radio-opacity, electrical insulation, anti-microbial, dimensional stability and other advantages. These properties help extend part life and enhance performance of many medical devices. Some uses include diagnostics, analysis, immunoassay testing, autoclavable caddies, orthopedic trials, implants, craniomaxillofacial CMF implants, spinal cages, spinal support implants, surgical instrumentation, manifolds and many others.
Why Boedeker Plastics, Inc. for the Medical Industry?
Since 1984, we have specialized in the medical industry and offer a complete range of solutions from medical grade plastic materials to prototype and production, machined and injection molded parts the Boedeker Way. We are ISO 9001 & 13485 certified, 21 CFR 820 compliant and are FDA #3000199132 registered. For customers that have specific validation or qualification requirements we offer a full range of qualification and validation services.
We have worked closely with Research and Development, Engineering and Supply Chain personnel at medical device companies with our materials, parts and services. From small to large companies as they develop new products and devices helping with materials selection by application, materials supply, prototyping and production supply.
Over the years, we have built a multimillion dollar inventory of high performance biocompatible medical grade plastic and composite sheet, rod and tube which includes many FDA, USP Class VI, & ISO 10993 compliant plastics and an ISO certified precision machine to support our clients with the most challenging requirements for plastics only machined medical grade plastic and composite parts. Our entire inventory is coded for full traceability to give our customers peace of mind that have received what they ordered. Some of the materials and parts we supply are approved for body tissue contact and long-term implant applications. In addition, we offer injection molding for higher part volume requirements in application that require medical grade molded parts. All inventoried materials are available with cut to size and same day shipping service. For clients that have ongoing part requirements, we offer just-in-time (JIT) delivery with our customer inventory services.
We have a variety of secondary manufacturing processes that allow us to manufacture a complete medical part solution that meet the unique regulatory and application requirements of the medical industry. Some of these processes include assembly, laser marking, UDI laser marking, annealing, cryogenic deburr technology along with other processes.
We also specialize in technical services that include material selection by application, improved part design assistance, onsite consultation and more. We stand ready to put our 1,800 years of combined experience and services to work for you.
As an alternative to onsite consultation we offer our TelePlastics™ remote support service. This is a safe and secure remote solution, for the diagnosis and recommendation of plastic solutions, by our experienced Technical Service staff, utilizing the latest in telecommunication technology.
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