Build SaMD and SiMD That Are Ready For Market, Not Just Ready To Demo
What we Support
-
Software in a Medical Device (SiMD)
Embedded control software for surgical systems, diagnostics, monitors, pumps, and wearables. -
Software as a Medical Device (SaMD)
Mobile, desktop, and cloud applications that drive diagnosis, decision support, or digital therapy. -
Connected Ecosystems
Integration of devices, apps, EMR, and cloud platforms, designed and tested as one system. -
Software Architecture for Long-Life Devices
Modular, testable architectures that support new features, new hardware, and future releases. -
Verification and Automation
Risk-based verification with automated tests at unit, integration, and system levels so you enter formal V&V with fewer surprises. -
Cybersecurity Across Device, Network, and Cloud
Threat modeling, secure architecture, and documentation aligned with current FDA expectations.
Connect Software to end-to-end Product Development
Software is only one part of getting a device to market. Our teams also support product design and engineering, human factors, preclinical, clinical, and market access so your roadmap stays aligned from concept through commercialization.
Explore how software fits into our full product development capabilities



