Custom FDA Regulated Software Development

We have over 25 years experience writing custom medical device software development ensuring your projects are completed the right way, the first time.

Get to Market Sooner, Stronger and Better Prepared with Our End-to-End Solutions

Our specializations cover the entire lifecycle of medical device software development. We develop your solution from start to finish, reviewing your existing architecture with a technical assessment, handle your cloud solutions or LIS integrations, and much more. We have a proven process for quality system compliance, as well as a designated in-house team for software verification and validation.

We Provide Robust Software Development Solutions

  • Custom Development

    With Gener8, your software solution is specifically designed and implemented to the specifications of your project. We translate your complex biomedical algorithms into testable code. We verify your software to ensure that your development is correct and ready for approval.

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  • Cloud Solutions

    We are highly skilled in Medical Device Software Development and medical device data systems (MDDS) software as complete cloud-resident applications. From secure user authentication to the proper encryption, our team can help your solution meet all of the best practices outlined in the HIPAA guidelines, and more.

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  • Quality System Compliance Assessment

    You want to make sure your Medical Device Software Development solution meets FDA requirements. Our quality assessment processes can help you pass compliance tests with flying colors.

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  • Technical Assessment

    A deep-dive into your project’s software design and source code to provide your team with new insights on how to make your solution even better. Gener8’s experience with medical device software development can help you drill down to what your software truly needs.

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  • Software Verification and Validation

    Your FDA compliance requires all design inputs to be verified through your design outputs. Let our independent engineers move your medical device software development through the process.

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  • LIS and EHR Integration

    Gener8 offers LIS and EHR integration services for both released medical device software products and those medical device software products still in development.

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  • FDA Assessment

    The FDA Readiness Assessment is a packaged service designed to provide an independent assessment of a company’s product prior to submitting for FDA approval. Click here to contact us regarding your FDA assessment needs. 

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We Commercialize Disruptive Technologies

Our automation and miniaturization capabilities are perfect for NGS instruments, library preparation systems, PoL and PoC IVD instruments using CRISPR and Cas enzymes and single-cell analysis equipment.

We have deep expertise in the development and manufacturing of state-of-the-art IVD, PoC and PoL molecular diagnostic instruments, automated and semi-automated immunostaining instruments and many other medical devices.

We'll help you get ahead of the competition with our industrial product development and manufacturing capabilities. We have a long history of development of advanced imaging systems, photonics systems, and various custom precision electronics.

Our software products are designed to meet your needs.

Application Accelerator is a proven software architecture and framework of services leveraged to jump start the development of custom software solutions.

The LIS Connector provides immediate connectivity between medical device software products and LIS or EHR systems, and customized for other customer-specific needs.

The Device Portal is a secure, cloud-based solution for managing medical device instruments via the web, eliminating the need to deploy field service personnel.

Thousands of projects completed.

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

Instruments & Devices


Microfluidic Cartridges & Consumables