Risk management at every phase.
We pride ourselves on our attention to detail and thoughtful design with every project.
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Strategy & Feasibility
Our seasoned leaders specialize in cutting-edge technology strategy and feasibility. We bring clients’ visions to reality.
We then use rapid prototyping and quick concepts to ensure that the end solution meets the customer and user needs.
We pride ourselves on our attention to detail and thoughtful design with every project we approach. Gener8 is certified to ISO 9001:2015 and ISO 13485:2016 and complies with ISO 14971 for medical device risk management.
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Concept Development
We begin with understanding your commercial objectives. From user experience to industrial design and product architecting, our concept phase provides a solid foundation for project success.
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Product Development
With an understanding of user needs and a feasible product concept, our engineers and designers create the CAD needed to prototype “Alpha” units to test functionality and use in order to refine the design to meet the requirements.
After reducing the risk on Alpha units, risk management continues as Beta units are built, further refining the design and displaying the potential manufacturing variation.
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Verification/Validation
After building successful Beta units, it’s time to build additional units for design verification and validation. The process can include EMI and Safety testing verification to ensure all design outputs meet the specified inputs, and validation can be achieved through clinical trials or additional use testing. The product is then ready for transfer to manufacturing at Gener8.
State of the art facilities and equipment for instrument and consumable development
Environmental Chambers
Rapid Prototyping
CNCs
Injection Molding Equipment
Laser Welding
Sonic Welding
Controlled Environment Rooms
<10% Humidity Dry Rooms
Testing Labs
