Most device recalls trace back to the software. We build the firmware, embedded systems, and device control software that clinical hardware runs on — engineered for real clinical conditions, not just the bench.
Talk to Us About Your Device Software
Medical device software occupies a position in engineering with no real parallel in other software disciplines. Every decision has to hold up across three dimensions at once — and a decision that's right on one can be wrong on the others.
A missed deadline isn't a slow user experience — it's a clinical failure. Memory and power constraints are fixed before the software team arrives. These constraints have no equivalent in application development.
IEC 62304, ISO 14971, IEC 62366, 21 CFR Part 820, and the 2023 FDA cybersecurity guidance — with post-market obligations that keep generating documentation requirements long after clearance.
A bug in a consumer app is a bad experience. A bug in infusion pump firmware or ventilator control software is a patient safety event.
Embedded systems, firmware, and device control software across the clinical hardware spectrum — each with its own safety classification, real-time constraints, and regulatory pathway.
Medical device software carries a regulatory load with no equivalent in other software. These are the five frameworks that shape every decision — and we build to the classification that applies, not the one that's convenient.
Three safety classes (A/B/C) based on harm severity. Class C applies when failure could cause serious injury or death. Most therapy and monitoring software lands Class B or C — full lifecycle documentation required.
Design planning, inputs, outputs, verification, validation, and transfer — all documented as you build. Design control gaps are the most common FDA inspection finding. We build the record during development, not before submission.
Hazard identification, risk estimation, control, and residual evaluation for every risk-contributing component. A living analysis that shapes design decisions, not documents them after.
Threat modeling, a Software Bill of Materials, patch management planning, post-market cybersecurity monitoring, and coordinated vulnerability disclosure. Required for networked devices at submission.
Use-related risk analysis, formative studies during design, and summative validation with real users. Usability failures are a leading cause of 510(k) additional information requests.
The technical content resembles ordinary embedded development. The process around it does not. Hover or tap a stage to see what it involves.
Precise, verifiable, traceable — not user stories. This phase takes longer and prevents late-stage problems that cost far more.
RTOS, memory, bootloader, and communication protocol chosen with post-market maintenance in mind — not just immediate development.
Test protocols written against requirements, not code. Every requirement traces to a test case through the full lifecycle.
Boundary conditions, race conditions, power loss, and concurrent events that clinical environments produce — not just nominal operation.
Software Description, Development Plan, Requirements Spec, and V&V documentation — produced as the software is built, not reconstructed at submission.
Each result ties to a real device and a real engineering constraint. Click through to see what was behind the metric.
Talk to Us About Your Device SoftwareClearance is not the end of the regulatory relationship. We build the post-market infrastructure during initial development — not when the first post-market issue surfaces. Hover a card to see how.
Every standard is scoped during discovery and built in during development — not retrofitted at submission time.
Lifecycle, risk, usability, and functional safety frameworks — applied to your device's safety class.
QMS and design control records ready for FDA review.
IEC 60601 software requirements — electrical context, EMC immunity, and alarm-condition logic.
Threat modeling, SBOM, and post-market monitoring for networked and AI-driven clinical software.
Standards-based data exchange to EMR and clinical systems.
Submission and regulatory frameworks across major device markets.
Firmware, RTOS, processors, clinical UI, communication, on-device AI, and the verification tooling an IEC 62304 lifecycle requires.
Primary firmware language. Built to MISRA-C safety coding standard for medical device software.
Used for device control software and complex embedded logic where C++ object model adds value.
Applied where timing demands leave no margin — interrupt handlers and boot-critical routines.
Default RTOS for Cortex-M devices. Open-source, widely validated, and IEC 62304-friendly.
Linux Foundation RTOS used on Nordic nRF and other connectivity-focused MCUs.
Azure RTOS — used in regulated environments requiring a safety-certified RTOS.
POSIX-compliant RTOSes for high-reliability applications — surgical, infusion, and imaging.
Primary processor family across our device portfolio — M-series for MCU, A-series for application processors.
STM32 for control-plane firmware, NXP i.MX for devices requiring Linux + real-time cores.
Go-to for BLE-connected wearables and monitoring devices. Paired with Zephyr RTOS.
Embedded and desktop clinical UI. IEC 62304-compliant UI development with GPU acceleration.
Companion apps for patient-facing mobile interfaces paired with device firmware.
Workstation and clinician-facing web UI for device management and data visualization.
BLE 5.x for wearables and monitoring devices. Wi-Fi and Zigbee for connected infrastructure.
Standards-based clinical data exchange from device to EHR and downstream clinical systems.
Imaging acquisition and transfer standard for diagnostic imaging devices and workstations.
Deterministic bus used in surgical and infusion devices. SPI / I2C / UART for peripheral sensors.
On-device inference for SaMD applications — arrhythmia detection, CGM calibration, image analysis.
Algorithm development and model-based design for signal processing and control system software.
Static analysis for MISRA-C compliance, runtime error detection, and IEC 62304 V&V evidence.
Unit test frameworks for embedded C and C++ under IEC 62304 verification requirements.
Requirements and traceability management. Bidirectional trace from requirement to test case.
Controlled branching strategy with tagged release baselines matching IEC 62304 configuration management.
Built right, device software is what clears your 510(k) and holds up in the ICU. Built wrong, it's what surfaces in a warning letter. Thirty minutes. No pitch.
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The technical content is similar. The documentation, process, and verification rigor is entirely different — formal requirements traceable to verified test cases, systematic risk analysis, configuration management that maintains a complete record of every released build, and design controls an FDA investigator can review. The consequence of getting any of it wrong is a regulatory finding or a patient safety event.
Determined during initial risk analysis, based on the severity of harm from software failure. Most therapy delivery, monitoring, and alarm software is IEC 62304 Class B or C. We determine this during discovery because it shapes the entire development process.
Yes — it's the most common engagement model. We work from hardware specifications, schematic reviews, and hardware bring-up collaboration. We don't treat the hardware as a black box.
We build all software regulatory documentation during development, so when submission time comes the documentation already exists. We work alongside your regulatory affairs team and can connect you with regulatory counsel if needed.
We build the post-market change management infrastructure during initial development. Updates follow the same design control process. Whether a specific change requires a new FDA submission depends on its nature and significance — we help clients work through this rather than applying a blanket policy.
You do. Full transfer at project close — source code, design documentation, test protocols, and regulatory documentation. No per-device licensing fees.
