Solutions Services Markets About Connect 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. Instruments & Devices Medical Consumables 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 Offers Turnkey Medical Development and Manufacturing Complete Assembly & Quality Control Testing Controlled Environment Rooms 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 Development/Design Manufacturing Expertise 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. In Vitro Diagnostics (IVD) Molecular Diagnostics (MDx) Imaging & Laser Devices Ophthalmic Diagnostics Monitoring Devices Surgical Instruments Diagnostic Imaging Medical Lasers Solid-State Laser Systems Diode Laser Systems Gener8 Success with Us Click below for more information on how we can help. Contact Gener8 Copyright © 2021. Gener8, LLC. All rights reserved.