Medical Devices & Bio-Technology
Healthcare products present a wide range of applications for injection molded components and assemblies, each with a unique set of requirements. In most instances, regulatory demands include the certification and maintenance of US FDA Drug Master Files and/or Device Master Files, resin biocompatibility records in the form of ISO 10993 or USP Class VI certifications, UL and/or EU food contact certifications, RoHS certification covering the restriction of hazardous substances, and UL- 94 certifications covering flammability. Any number of these requirements can apply to injection molded components in this market, as well as more specific prerequisites such as sterilization.
PILLER AIMMCO has a history of successfully working with clients in the medical device and bio-pharmaceutical industries to develop components for the handling and management of fluids, drug delivery & detection, orthopedic devices, laboratory components & devices, clinical devices and orthodontic instruments. We welcome the opportunity to collaborate with clients in these industries to solve tooling and molding challenges, and to demonstrate our commitment.
Biological PCR Test Vial
Hand-Held Ultrasound Device Component
Over-Molded Surgical LED Headband