Instrument and Consumable Manufacturing and Commercial Services

We offer expertise in complex electromechanical assembly, plastic injection molding (microfluidics), and commercial services, including fulfillment and repair.

We specialize in highly complex instrument and consumable assembly and commercialization

  • New Product Introduction

    Gener8’s NPI team owns the design transfer process to enable robust transitions from development to manufacturing. Working closely with the product design team, late stage engineering deliverables such as verification, DFx, process development, process validation, and supplier quality control are completed. Gener8’s NPI team creates and continuously improves upon work instructions, assembly fixtures and tooling. Gener8’s Test team also develops test systems, including hardware fixtures and associated software, in order to automate test execution and performance data collection. 

    Gener8’s NPI team engages with both internal and external partners at any stage of the design transfer process in order to ensure smooth transition to manufacturing in compliance with Current Good Manufacturing Practice (CGMP) and other industry standard 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.

CP1A9444
  • 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.

Electromechanical Contract Manufacturing
  • 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.

Specialized Cleanroom Manufacturing Services
  • 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.

CP1A8828

We provide cost-effective turnkey manufacturing of instruments and consumables.

Thousands of projects completed.

We're proud to serve the Biotech, Medical, and Industrial markets.

Instruments & Devices

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Microfluidic Cartridges & Consumables

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Clients

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