Comprehensive Device Software Services

From mobile apps to embedded firmware, from initial development to FDA submission — and medical-grade private AI. We handle every aspect of your medical device software.

Discuss Your Project

Device Software Development

iOS, Android, and Desktop applications that seamlessly connect to your medical devices.

We build native applications that communicate with your devices using BLE, Bluetooth Classic, WiFi, Serial, and other protocols. Our apps are designed for reliability, user experience, and FDA compliance.

Learn More

What We Deliver

  • Native iOS development (Swift, Objective-C)
  • Native Android development (Kotlin, Java)
  • Windows & macOS desktop applications
  • Cross-platform solutions when appropriate
  • Real-time data visualization
  • Cloud connectivity and sync

Firmware Development

Embedded software that speaks the language of your hardware.

From bare-metal embedded C to RTOS-based systems, we develop the firmware that powers your device. We handle communication stack implementation, sensor integration, and power optimization.

Learn More

What We Deliver

  • Embedded C/C++ development
  • BLE, Bluetooth, WiFi stack implementation
  • Sensor integration and calibration
  • Power management optimization
  • Bootloader and OTA update systems
  • Custom protocol development

Verification & Validation

10+ years of V&V experience with Fortune 500 medical device companies.

Our V&V team has extensive experience with FDA submissions and regulatory requirements. We develop comprehensive test protocols, execute testing, and deliver documentation that passes regulatory scrutiny.

Learn More

What We Deliver

  • FDA 21 CFR Part 11 compliance
  • IEC 62304 software lifecycle
  • Test protocol development
  • Traceability matrices
  • Risk analysis (FMEA, ISO 14971)
  • Design history file documentation

QA & Testing

Rigorous testing that finds bugs before your users do.

We test across devices, OS versions, and protocols to ensure your software works reliably in the real world. Our automated testing infrastructure catches regressions early.

Learn More

What We Deliver

  • Manual and automated testing
  • Device compatibility testing
  • Protocol conformance testing
  • Performance and stress testing
  • CI/CD pipeline integration
  • Bug tracking and resolution

Architecture & Modernization

Independent architecture audits and platform decomposition for medical device software.

We turn legacy monoliths into modular, independently-releasable platforms without breaking FDA validation. Pattern-literate in Strangler Fig, anti-corruption layers, hardware abstraction layers, and modular monoliths, applied where the system needs them. IEC 62304 and DHF-aware throughout. Refactor, not rewrite.

Learn More

What We Deliver

  • Independent software architecture audits
  • Platform decomposition strategy
  • Refactor roadmaps with risk + regulatory blast-radius assessment
  • Strangler Fig and anti-corruption layer execution
  • Architecture Decision Records (ADRs)
  • C#/.NET and Windows desktop deep specialty

Medical-Grade Private AI

AI features on privately-hosted, SOC 2-attested infrastructure — your data never trains a third-party model.

We build AI into medical and healthcare software using open-source models on private, SOC 2-attested inference infrastructure, so sensitive data stays inside your boundary and is never used to train someone else’s model. Designed for IEC 62304 and ISO 14971, with FDA AI/ML expectations (GMLP, PCCP) in mind.

Explore Private AI

What We Deliver

  • Open-source models on private / dedicated inference
  • SOC 2-attested hosting (e.g. Fireworks AI, Bedrock, Azure)
  • No training on your data; data-isolation by design
  • HIPAA-eligible hosting options for PHI workflows
  • Validation & V&V approach for AI/ML features
  • On-prem / VPC options to avoid vendor lock-in

Every Platform You Need

We develop for all major platforms, ensuring your device software reaches users wherever they are.

iOS

iPhone & iPad

Android

Phones & Tablets

Windows

Desktop & Kiosk

macOS

Desktop Apps

Web

Cloud & Portals

Embedded

Linux & RTOS

Medical Device Software Services: FAQ

What medical device software services do you provide?

Device software (iOS, Android, Windows, macOS), embedded firmware, verification & validation to IEC 62304 and FDA standards, QA and protocol testing, architecture audits and modernization, and medical-grade private AI — across the full lifecycle from prototype to FDA submission.

Do you develop software to FDA and IEC 62304 standards?

Yes. We develop under the IEC 62304 software lifecycle with ISO 14971 risk management, produce verification & validation records and traceability matrices, and deliver Design History File documentation suitable for FDA premarket submissions.

Can you join an existing medical device project mid-stream?

Yes. We integrate with in-house teams or take ownership of a workstream, including legacy codebases that need an IEC 62304 gap assessment, architecture audit, or V&V remediation before submission.

Ready to Get Started?

Tell us about your project and we'll help you determine the best approach.

Schedule a Consultation