sterilization validation

C&J Industries is a full-service plastic injection molding contract manufacturer and FDA-certified medical device manufacturer based in Meadville, Pennsylvania. The company offers product design and development, in-house tooling, plastic component manufacturing, assembly, decorating, packaging, and distribution. It is ISO 13485:2016 and ISO 9001:2015 certified and has been FDA registered for medical devices and plastic molded components since 1981.

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cleanroom moldingCNC ultrasonic weldingcontract manufacturingfully automatic assemblyheat stakinglaser etchingmedical injection moldingmold flow simulationpackagingpad printingplastic injection moldingproduct design and developmentrapid prototypingsemi-automatic assemblysurface coatingtoolingtwo-shot molding

EEA Innovations specializes in medical device development, delivering engineering, regulatory, testing, and commercialization services. With over two decades of experience, the team has developed 10+ FDA-cleared products and operates within a QMS aligned with ISO 13485 and IEC 62304, partnering with innovators to fast-track medical technologies, software, and devices from concept to commercialization.

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3D printingbiological evaluation (ISO 10993)design for manufacturingdesign transferEMC safety testingmachiningmedical device developmentmoldingpackaging designpackaging validationprocess validationQMS (ISO 13485)rapid prototypingregulatory strategyrisk management (ISO 14971)software development (IEC 62304)supplier qualificationusability testing (IEC 62366)verification and validation