We specialize in highly complex instrument and consumable assembly and commercialization
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New Product Introduction
Gener8’s proven new product introduction process enables a smooth transition from product design development to design transfer to manufacturing in compliance with Current Good Manufacturing Practice (CGMP) regulations. Our approach allows for customers to transfer design engineering files to our contract manufacturing services in a short period of time while maintaining the highest manufacturing transfer standards.
Gener8's new product introduction process consists of creating work instructions, fixtures, tooling, software, and test programs necessary for a robust transition from development to manufacturing. Gener8 delivers product quality excellence and manufacturing consistency once the new product introduction process is completed.
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Electromechanical Contract Manufacturing Services
We offer manufacturing capabilities in high technology electromechanical box assembly, printed circuit board, cable, electrical test, and system testing solutions.
Our experienced manufacturing workforce can support a 24/7 build schedule of your complex electromechanical and device production build requirements.
Our manufacturing execution systems provide traceability, inspection, and test records and are kept electronically, and are compliant with ISO 9001 and ISO 13485 quality system standards. Our manufacturing services provide robust process controls and quality inspection methods to ensure your product is manufactured to the highest reliability and quality standards.
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Specialized Controlled Environment Room Manufacturing
Gener8 offers controlled environment rooms. Our temperature, humidity, and particle count control systems allow us to assemble microelectronics, injection-molded plastic assemblies, and cartridge reagent filling meeting ISO 13485 and 21 CFR Part 820 manufacturing requirements. Our dry room capabilities (< 10% RH humidity) allow lyophilized reagents to be assembled into and stored on-board our manufactured cartridges.
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Instrument Service & Repair
Gener8 also provides complete life-cycle support services including service and repair capabilities for your field units.
We leverage our strong engineering expertise into a formidable field technical support service and repair operation. In addition, we offer troubleshooting and repair programs for complex instruments we design and manufacture.
We provide cost-effective turnkey manufacturing of instruments and consumables.
