Medical Instrument and Consumable Development and Manufacturing

Developing innovative medical devices with wide-ranging experience and industry-leading expertise.

We bring your medical device to market

We offer comprehensive and robust development services for medical devices and consumables to reduce risk and shorten your time to market. Our quality team is integrated into all steps along the way to assure we're meeting your ISO 13485 requirements.

We are seasoned in bringing innovative medical devices to market and our engineering, design and manufacturing teams are tenured in user experience, design for manufacturability, and reliability. Our strengths in manufacturing include extensive prototyping abilities and offer flexibility and customizability, supplemented by a team of skilled manufacturing, assembly, and engineering level technicians.


We Commercialize Medical Instruments and Consumables

Whether you need instrumentation such as a molecular point-of-care (PoC) diagnostic device or a more complex radiation or imaging system, our staff of engineers, scientists, and designers can meet your medical device needs.

We are proud to be at the front end of breakthrough diagnostic and molecular PoC product development, including in-vitro diagnostics (IVD), and immunohistochemistry devices. Additional specialties include diagnostic imaging devices, laser systems, therapeutic equipment, surgical hardware, and other complex instrumentation. Our engineering team specializes in optics-based detection systems and fluidics.

Gener8 is focused and highly skilled in medical consumable product development. Our deep expertise is in point of care (PoC) microfluidic cartridge development along with general clinical products and more advanced omics devices.

If you're looking for Clinical Laboratory Improvement Amendments (CLIA) waivable product development, we have you covered. Iteration is key when developing plastic consumable devices and stereolithography (SLA) and 3D printing can only get you so far.

With our rapid plastics injection molding capabilities, we can iterate on actual part designs using commercial-ready materials. We are your fastest solution to market.

Gener8 Offers Turnkey Medical Development and Manufacturing

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Complete Assembly & Quality Control Testing


Controlled Environment Rooms

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Injection Molding & Plastics Processing


Certified to ISO 13485 Quality Standards


Reagent Filling in Our Dry-Room Space


Regulatory Support

Your solutions partner for Class II and Class III medical products

Experts in breakthrough medical technologies including IVD, Molecular Diagnostics, and Imaging

Our focus is on in-vitro diagnostics (IVD), molecular diagnostics (MDx), and imaging and laser devices.

  • Molecular Diagnostics
    • Polymerase Chain Reaction (PCR)
    • Next-Generation Sequencing (NGS) and Third-Generation Sequencing (TGS)
    • Clinical Chemistry Instrumentation
  • Point of Care (PoC) Molecular Diagnostics
    • Real-Time PCR
  • Immunohistochemistry
    • PoC Clinical Chemistry
  • Lateral Flow Immunoassays
    • Rapid Tests
    • Enzyme-Linked Immunosorbent Assay (ELISA) and Other Technologies
    • Enzyme Immunoassays (EIA)
  •  Consumables
    • Immunohistochemistry 
    • Immunostaining Consumables
    • PoC consumables
  •  Instruments
    • Automated and Semi-Automated Immunostaining Instruments
    • PoC Analyzers
    • Automated Immunoassays Instruments
  • Instruments
    • Digital PCR (dPCR) Systems 
    • Quantitative PCR (qPCR) Equipment 
    • PoC Real-Time PCR Analyzers and Automated systems
    • Single-Cell PCR Instruments
  • Consumables
    • dPCR, qPCR, and Single-Cell PCR
    • PCR Nano or Microfluidic Consumables
    • PoC Real-Time PCR Consumables
  • Ophthalmic
    • Diagnostics
    • Monitoring Devices
    • Surgical Instruments
  • Diagnostic Imaging
  • Medical Lasers
    • Solid-State Laser Systems
    • Diode Laser Systems

ISO 13485 Quality Management System

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