Aptyx is a newly unified manufacturing company built on more than 70 years of expertise from pioneering businesses in complex plastics processing. With more than 1,000 team members across facilities in four countries, it supports demanding medical-device programs and other mission-critical applications through integrated engineering and production. Its ISO 13485:2016 certification reflects the quality systems behind that work.
ISO 13485:2016
certification
FDA registered
registration
ISO 9001:2015
certification
ITAR registered
registration
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
AtalysAtalys 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.CLOVERDALE, OH