Medical device software and embedded systems engineering for FDA-regulated products
Full Spectrum is a vertical specialist in medical device and embedded systems development, with four decades of FDA-regulated product delivery and ISO 13485 certification since 2009. The tech stack—C++, Linux, RTOS, Qt, Rust, and a deep embedded toolchain (STM32, NXP i.MX, EtherCAT, CAN Bus)—reflects a company built around real-time, safety-critical systems rather than cloud or web infrastructure. Active projects span surgical displays, autonomous robotics, physiological data systems, and BLE/Wi-Fi medical connectivity, while pain points cluster heavily around FDA compliance, V&V strategy, and risk analysis—revealing that regulatory excellence and internal process maturity are the true competitive moats.
Full Spectrum develops software and embedded systems for medical device manufacturers and digital health companies, operating as a full-responsibility partner from concept through FDA clearance and field deployment. The company has completed over 1,000 development programs since 1982, spanning Class III devices, robotics, algorithm-driven diagnostics, and cybersecurity-hardened systems. Work includes technology consulting, systems engineering, custom PCB design, and verification & validation services. The organization is based in Westborough, Massachusetts, with a lean engineering-heavy team (13 engineers across principal and director-level roles) and minimal commercial headcount, reflecting a services model driven by deep technical credibility rather than broad sales coverage.
C++, Linux, RTOS, Qt, Rust, and embedded platforms including STM32 and NXP i.MX. Also uses EtherCAT, CAN Bus, BLE, Wi-Fi, and Altium Designer for PCBA work.
Mobile apps for medical hardware, surgical display systems, autonomous robotics, real-time physiological monitoring, BLE/Wi-Fi device interfaces, and FDA regulatory pathway development.
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