Atalys is a Rochester-based medical device contract manufacturer that designs precision tooling and molds and produces intricate plastic components, often to micron-level tolerances, for critical surgical and drug-delivery applications. Its vertically integrated platform spans engineering, molding, automation and assembly across manufacturing sites in the United States and the Dominican Republic, with nearly 60 years of injection-molding experience and more than 500 years of in-house mold-making experience. Atalys’s quality systems include ISO 13485:2016-certified manufacturing sites, an ISO 9001:2015-certified engineering center and an FDA-registered facility.
ISO 13485:2016
certification
ISO 9001:2015
certification
FDA-registered facility
registration
Empire Precision PlasticsFounded in 1992, Empire Precision Plastics is a Rochester-based contract manufacturer of close-tolerance plastic parts, developing programs from tooling and prototypes through scientific injection molding and assembly. Its almost 70,000-square-foot facility combines an in-house tool room with highly automated molding and controlled-environment capabilities, including specialized work in medical devices and polymer optics. Empire is certified to ISO 9001:2015 and ISO 13485:2016, and has completed more than 1,000 injection-mold tooling transfer programs.ROCHESTER, NY
Quality Tool & Die / QTD PlasticsFounded in 1977, Quality Tool & Die began as a tool-and-die and precision machining shop and has grown into a contract manufacturer that builds molds and produces plastic-injection-molded components, with QTD Plastics focused on medical devices since 2014. Its in-house toolmaking and molding operations support projects from mold development through validated production, and the company is FDA registered for medical-device manufacturing. Tooling and machining are certified to ISO 9001:2015, while injection molding operates under ISO 13485:2016.MEADVILLE, PA
Polymer MedicalOrchard Park’s Polymer Medical makes contract injection-molded plastic components and finished devices for healthcare and bioscience companies. Led by plastics-industry veterans Ben Harp and Tom Rybicki, the company carries projects from tooling and prototyping through cleanroom assembly, with particular experience in complex, critical-to-life applications. Polymer Medical is ISO 13485:2016 certified for contract plastic injection molding and manufacturing of medical devices and components.ORCHARD PARK, NY
Plastikos, IncFounded in Erie in 1989, Plastikos is a second-generation, family-owned manufacturer of complex, tight-tolerance plastic components through precision injection molding and in-house tooling. Its work is concentrated in patient-critical medical devices and customized electronic connectors, supported by ISO 7 and ISO 8 cleanrooms and more than 100,000 square feet of combined facilities. Plastikos is ISO 13485 certified and ships more than 700 million parts annually from its U.S. operations.ERIE, PA