The Technical Requirements Are Tighter
A missed deadline isn't slow UX — it's a clinical failure. Memory and power constraints are fixed before the software team even arrives.
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Why Medical Device Software Is Its Own Discipline
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.
The Regulatory Requirements Are More Demanding
IEC 62304, ISO 14971, IEC 62366, 21 CFR Part 820, and 2023 FDA cybersecurity guidance — with post-market obligations long after clearance.
The Consequences of Failure Are More Serious
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.
Device Categories We Build Software For
Embedded systems, firmware, and device control software across the clinical hardware spectrum — each with its own safety classification, real-time constraints, and regulatory pathway.
What FDA Regulation of Device Software Actually Requires
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.
IEC 62304 — Software Lifecycle
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.
21 CFR Part 820 — Design Controls
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.
ISO 14971 — Risk Management
Hazard identification, risk estimation, control, and residual evaluation for every risk-contributing component. A living analysis that shapes design decisions, not documents them after.
FDA Cybersecurity Guidance 2023
Threat modeling, a Software Bill of Materials, patch management planning, post-market cybersecurity monitoring, and coordinated vulnerability disclosure. Required for networked devices at submission.
IEC 62366 — Usability Engineering
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.
How We Build
The technical content resembles ordinary embedded development. The process around it does not. Hover or tap a stage to see what it involves.
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Requirements to IEC 62304
Requirements to IEC 62304
Precise, verifiable, traceable — not user stories. This phase takes longer and prevents late-stage problems that cost far more.
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Architecture for the Full Lifecycle
Architecture for the Full Lifecycle
RTOS, memory, bootloader, and communication protocol chosen with post-market maintenance in mind — not just immediate development.
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Verification Designed In
Verification Designed In
Test protocols written against requirements, not code. Every requirement traces to a test case through the full lifecycle.
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Hazard Analysis Covers the Edge Cases
Hazard Analysis Covers the Edge Cases
Boundary conditions, race conditions, power loss, and concurrent events that clinical environments produce — not just nominal operation.
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Regulatory Docs Built During Development
Regulatory Docs Built During Development
Software Description, Development Plan, Requirements Spec, and V&V documentation — produced as the software is built, not reconstructed at submission.
Device Software We've Shipped. What the Numbers Showed.
Each result ties to a real device engineering constraint.
Talk to Our Team510(k)
Cleared first submission — Infusion Pump Firmware (Class IIb). 99.97% dose accuracy in clinical validation.
8.2%
MARD — Continuous Glucose Monitor. Calibration accuracy across physiological edge cases. FDA De Novo granted.
94 days
To EUA — Ventilator Control Software. Full IEC 62304 Class C lifecycle. Zero safety events in 18 months field deployment.
0.1mm
Positioning accuracy — Surgical Robot Motion Control. Sub-10ms fault detection. 510(k) cleared.
97.3%
Sensitivity, 94.1% specificity — Cardiac Monitor AI Arrhythmia Detection (SaMD). De Novo granted.
99.99%
Communication reliability — Implantable Neurostimulator Programmer. 18-month battery life achieved.
Post-Market Is Where Most Organizations Underestimate the Work
Clearance isn't the end — we build post-market infrastructure during development, not when the first issue surfaces. Hover a card to see how.
Documented Change Control
Every post-clearance change runs through documented change control, and we flag which need a new FDA submission.
MDR & Adverse Event Reporting
Complaint handling and the MDR workflow built in from the start, so reportable adverse events file cleanly.
Post-Market Cybersecurity
The 2023 FDA guidance adds ongoing duties: vulnerability monitoring, patching timelines, and coordinated disclosure.
Regression & Real-World Feedback
A regression suite verifies every post-market change against the full requirement set and risk management file.
Compliance & Standards We Treat as Engineering Inputs, Not a Checklist
Every standard is scoped during discovery and built in during development — not retrofitted at submission time.
Safety Lifecycle
Software Lifecycle & Risk
Lifecycle, risk, usability, and functional safety frameworks.
Quality System
Quality & Design Controls
QMS and design control records ready for FDA review.
Electrical Safety
Electrical Safety, EMC & Alarms
IEC 60601 electrical safety, EMC immunity, and alarm-condition logic.
Security & AI
Cybersecurity, SaMD & AI/ML
Threat modeling, SBOM, and post-market monitoring for AI-driven software.
Interoperability
Interoperability & Connectivity
Standards-based data exchange to EMR and clinical systems.
Global Access
Global Market Access
Submission and regulatory frameworks across major device markets.
The Tech Stack We Build Device Software On
Firmware, RTOS, processors, clinical UI, communication, on-device AI, and the verification tooling an IEC 62304 lifecycle requires.
C (MISRA-C)
Primary firmware language. Built to MISRA-C safety coding standard for medical device software.
C++
Used for device control software and complex embedded logic where C++ object model adds value.
Assembly
Applied where timing demands leave no margin — interrupt handlers and boot-critical routines.
FreeRTOS
Default RTOS for Cortex-M devices. Open-source, widely validated, and IEC 62304-friendly.
Zephyr
Linux Foundation RTOS used on Nordic nRF and other connectivity-focused MCUs.
ThreadX
Azure RTOS — used in regulated environments requiring a safety-certified RTOS.
VxWorks / QNX
POSIX-compliant RTOSes for high-reliability applications — surgical, infusion, and imaging.
ARM Cortex-M/A
Primary processor family across our device portfolio — M-series for MCU, A-series for application processors.
STM32 / NXP i.MX
STM32 for control-plane firmware, NXP i.MX for devices requiring Linux + real-time cores.
Nordic nRF
Go-to for BLE-connected wearables and monitoring devices. Paired with Zephyr RTOS.
Qt (Embedded)
Embedded and desktop clinical UI. IEC 62304-compliant UI development with GPU acceleration.
React Native
Companion apps for patient-facing mobile interfaces paired with device firmware.
React.js
Workstation and clinician-facing web UI for device management and data visualization.
BLE 5.x
BLE 5.x for wearables and monitoring devices. Wi-Fi and Zigbee for connected infrastructure.
HL7 FHIR
Standards-based clinical data exchange from device to EHR and downstream clinical systems.
DICOM
Imaging acquisition and transfer standard for diagnostic imaging devices and workstations.
CAN bus
Deterministic bus used in surgical and infusion devices. SPI / I2C / UART for peripheral sensors.
TensorFlow Lite
On-device inference for SaMD applications — arrhythmia detection, CGM calibration, image analysis.
MATLAB / Simulink
Algorithm development and model-based design for signal processing and control system software.
Polyspace
Static analysis for MISRA-C compliance, runtime error detection, and IEC 62304 V&V evidence.
Unity / CppUTest
Unit test frameworks for embedded C and C++ under IEC 62304 verification requirements.
DOORS / Jama
Requirements and traceability management. Bidirectional trace from requirement to test case.
Git
Controlled branching strategy with tagged release baselines matching IEC 62304 configuration management.
The Software Inside Your Device Will Determine More Than You Think
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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Frequently Asked Questions
[ 1 ]
How is this different from regular embedded development?
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.
[ 2 ]
What safety classification will our software be?
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.
[ 3 ]
Can you work alongside our hardware team?
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.
[ 4 ]
How do you handle FDA submission preparation?
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.
[ 5 ]
What happens when we need to update software after clearance?
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.
[ 6 ]
Who owns the IP?
You do. Full transfer at project close — source code, design documentation, test protocols, and regulatory documentation. No per-device licensing fees.
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