Family-owned and based in Cincinnati, Elite Precision Plastics grew out of healthcare supply-chain needs during the COVID-19 pandemic. A subsidiary of Elite Biomedical Solutions, it brings more than a decade of healthcare-manufacturing heritage and a team with over 75 years of cross-industry process-engineering experience to precision injection molding for highly regulated customers. Its ISO-certified quality systems include ISO 13485:2016 and ISO 9001:2015.
ISO 13485:2016
ISO 9001:2015
FDA Compliance
Compliance program
FDA 21 CFR 820
Compliance program
Current Good Manufacturing Practices (cGMP)
Compliance program
FDA
Quality certification
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
Plastikos, IncFounded in Erie in 1989, Plastikos makes complex, tight-tolerance plastic components through custom injection molding, with roots in precision mold design and fabrication. The second-generation family-owned company supplies patient-critical medical parts as well as specialized electronic connectors, producing more than 700 million parts a year across its U.S. operations. Plastikos operates ISO 7 and ISO 8 cleanrooms and holds ISO 13485 certification for medical-device manufacturing.ERIE, PA
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
MoldgenixMoldgenix carries forward a plastics-manufacturing legacy established in 1987 and now operates under the ownership of Haartz Family Holdings. The company is known for helping OEMs turn demanding designs into production through medical-focused plastic injection molding, supported by an FDA-registered facility and an ISO 13485:2016-certified quality system.TRUMBAUERSVILLE, PA