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.

Medical Monitor
When 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.

With decades of experience working with safety-critical software applications, we have “A 20-year head start” (to quote an FDA Consultant we work with) when it comes to designing, developing, and testing medical device software for regulatory submissions. Our experienced software engineering team provides you with the expertise and support you need—in our facility or yours.

Download our Medical Industry Brochure

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 technologies.

  • 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)
Business Man

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.


  • 9001:2015 QMS Certified
  • 13485:2016
  • 14971:2019 (Risk)
  • 31000 (Risk)
  • 13482:2014 (Robotics)
  • 16142 (Safety)
  • 81001-1:2021 (Security)


  • 60601/80601 (Electrical)
  • 62304 (SDLC)
  • 80001-1:2001 (Risk)
  • 62366(UX)


FDA 510(k) Premarket Notifications

CFR 820.30


Medical IV&V: Our Proven Process

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

Additional 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

Design & Prototyping

In addition to our robust Software Engineering capabilities, our team of electrical and mechanical engineers can work with you to design and build your medical device. We can tackle whatever the project, from a simple design review to full prototyping and production cycle management. Make your dream a reality with our engineering and manufacturing services.

General Digital: AS9100D & ISO 9001:2015 QMS Certified

Graphic of AS9100d & ISO 9001:2015 QMS Certified MarkGeneral Digital Corporation has been a leading provider of defense-related engineering services for decades, and our commitment to providing quality products and services is second to none. We are compliant with DFARS, NIST, and CMMC. All products and services are manufactured and performed at our AS9100D- and ISO 9001:2015 QMS-certified facility in East Hartford, Connecticut.

Ready to Engineer What’s Next?