We specialize in highly complex electro-optical and electro-mechanical assembly.
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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 to cGMP regulations. Gener8’s approach allows for customers to transfer design engineering files to our contract manufacturing services in a short period time while maintaining the highest manufacturing transfer standards.
The new product introduction process consists of the creation of work instructions, fixtures, tooling, software and test programs necessary for a robust transition from development to manufacturing. The advantage that Gener8 brings in the manufacturing transfer process is the engineering technician support which is unparalleled in the industry. Our objective is to deliver product quality excellence and manufacturing consistency once the new product introduction process is completed.
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Electromechanical Contract Manufacturing Services
We offer over 40,000 square feet of manufacturing space of high technology electromechanical box assembly, printed circuit board, cable, electrical test and system testing solutions.
Our experienced manufacturing workforce of over 150 personnel can support a 24/7 build schedule enabling on-time deliveries of the most complex electromechanical and device production build requirements.
We have introduced manufacturing execution systems where all traceability, inspection and test records are kept electronically compliant to ISO 9001 and ISO 13485 quality system standards. Our manufacturing services provide robust process controls and quality inspection methods to assure your product is manufacturing to the highest standards of reliability and quality.
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Specialized Controlled Environment Room Manufacturing Services
Gener8 offers three controlled environment room facilities compliant to ISO Class 7 and Class 8 standards.
Our temperature, humidity and particle count control systems allow us to assemble microelectronics, injection molded plastic assemblies and cartridge reagent filling meeting the most robust ISO 13485 and 21 CFR Part 820 manufacturing requirements.
In addition, we are in the process of introducing dry room capabilities in our Carlsbad, CA facility where we will provide lyophilization services for reagents.
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Field Service & Repair
The value of our contract manufacturing services is enhanced by Gener8’s complete product lifecycle support services. This includes field service support post shipment and in-house repair of instruments.
We have been able to leverage our strong engineering expertise into a formidable field technical support service and repair operation. We offer troubleshoot and repair programs for complex instruments we design and manufacture.
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Specialized Test & Measurement Capabilities
Gener8 offers unique technology test and measurement capabilities to support complex manufacturing builds. The list includes but not limited to:
- S-Parameter Network Analyzer
- Air Velocity Meter
- Hot Wire Anomometer
- UVAB Digital Light Meter
- 3plane Laser Level
- SMD Rework Station
- Oscilloscope
- Digital Angle Gauge
- UV Cure Lamp
- Spectrum Analyzer
- JST Crimper
- Minifit Crimper
- C-Grid Crimper
- Optical Laser Calibration System
- Optical and Coordinate Measuring Machines
Our facilities are fully equipped to handle all of your manufacturing needs.
Extensive Controlled Environment Rooms
Manufacturing Lab Space
Development Lab Space
50,000ft² of facilities devoted to manufacturing
$12 million of processing, testing, and development equipment
In-house mechanical prototyping capabilities
In-house electrical prototyping capabilities
