Medical Devices | Medical Diagnostic Equipment

Software Engineering, Design, Development and IV&V Testing

General Digital: Engineering What’s Next in Medical Device Systems

We design, program, verify, and integrate real-time software for medical devices, testing and diagnostic equipment, and other life-saving health field applications.

 

Photo of nurse using medical monitorWhen lives are on the line, medical software and technology can’t afford to fail.


General Digital is the medical industry’s trusted partner in safety, reliability, and performance. Our team can work on any certified Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) application.


Our experienced software development team provides you with the expertise and support you need—in our facility or yours.

 

Download our Medical Device brochure

 

General Digital: ISO 9001:2015 QMS Certified

Developed—and proven—to work in aviation and other certified environments, our proprietary software unit test tool, genIViVe™, continues to evolve, giving us (to quote an FDA consultant we work with) a “20-year head start” when it comes to unit testing in support of medical device compliance.

Ensure product safety and reliability Increase development and testing efficiency Get reliable, trusted, third-party objectivity Improve outcomes—and your bottom line

 

  Discuss your project with our team  

Medical Technology: Software Development

Our software development team offers a full suite of support for every stage of implementation, including embedded firmware development and software development in many languages.

  • C/C++, C#, Assembly
  • Ada, LabVIEW, Perl, Python
  • SGL, Ruby, Qt
  • Freescale/NXP, ARM, Renesas
  • WCF, WPF
  • Xamarin, Mono, XAML
  • Proprietary RTOS, Embedded Linux
  • Android, IOS
  • TCP-based protocols, CAN, Bluetooth
  • Many more

With the addition of our verification services, you benefit from a complete lifecycle solution. Call 800-952-2535 now or e-mail us to discuss your project with our team.

Independent Verification & Validation (IV&V)

Medical IV&V isn’t just about quality assurance. It’s about ensuring your safety-critical software and systems are built to stay healthy.

Since 1998, our engineers have been iterating and augmenting our proprietary suite of IV&V tools, GenIViVe™, to be one of the most robust, comprehensive and efficient unit testing tools available. Combined with our trained team of experienced on-shore engineers, we can account for every possibility, ensuring 100% product reliability—in accordance with the standards of certifying bodies.

 

Medical IV&V Standards
  • ISO
    • 9001:2015 QMS Certified
    • 13485:2016
    • 14971:2019 (Risk)
    • 31000 (Risk)
    • 13482:2014 (Robotics)
    • 16142 (Safety)
    • 81001-1:2021 (Security)
  • IEC
    • 60601/80601 (Electrical)
    • 62304 (SDLC)
    • 80001-1:2001 (Risk)
    • 62366(UX)
  • CE/MDR
  • FDA 510(k) Premarket Notifications
  • CFR 820.30
  • HIPAA

Medical IV&V: Our Proven Process

  • Requirements Development
  • Project Coordination
  • Tool Qualification
  • Discrepancy Resolution
  • Test Planning and Execution
  • Results Reporting

 

Photo of business man holding medical devicesAdditional IV&V Services

  • Implement test requirements
  • Provide a reliable method to outsource
  • Develop custom test requirements based on your software criticality level
  • Make test tool and simulator recommendations

Ready to Engineer What’s Next?

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Contact Info

GENERAL DIGITAL CORPORATION
60 Prestige Park Road
East Hartford, CT 06108
United States of America


860.282.2900 (Local & International)
800.952.2535 (Toll-Free U.S./Canada)


ISO 9001:2015 QMS Certified
ISO 9001:2015 QMS Mark
Click to verify our ISO 9001 certificate.