Secure, compliant software & systems for medical device startups

From embedded firmware to cloud platforms, we deliver FDA-compliant solutions that scale. Our AI coding agents accelerate routine development safely—not for "vibe coding", but to deliver audit‑ready quality faster.

Comprehensive Medical Device Development

One integrated team handles your entire technology stack. No coordination headaches between multiple vendors or communication gaps.

Embedded & Wireless Systems

Firmware development, BLE, Wi‑Fi, and cellular communication systems designed for medical device reliability and regulatory compliance.

  • Real-time embedded firmware
  • Bluetooth Low Energy (BLE)
  • Wi-Fi and cellular connectivity
  • Power-optimized designs
  • FDA cybersecurity compliance
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Connected Mobile & Cloud Apps

iOS, Android, and web dashboards with real‑time data visualization, secure cloud infrastructure, and seamless device integration.

  • Native iOS & Android apps
  • Real-time data dashboards
  • Secure cloud infrastructure
  • HIPAA-compliant architecture
  • Scalable data analytics
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ISO 13485-Compliant Documentation

Complete Device History Files (DHFs), IEC 62304 lifecycle documentation, risk controls, traceability, and usability engineering.

  • IEC 62304 lifecycle processes
  • Risk management (ISO 14971)
  • Design controls & traceability
  • Usability engineering
  • FDA submission support
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Technology Excellence

Modern, proven technologies combined with medical device expertise and regulatory compliance.

Hardware & Embedded

  • ARM Cortex microcontrollers
  • Nordic nRF series (BLE)
  • ESP32/ESP8266 (Wi-Fi)
  • STM32 development
  • Real-time operating systems
  • Power management design

Software & Cloud

  • React Native & Flutter
  • Swift & Kotlin native
  • Node.js & Python backends
  • AWS & Azure cloud platforms
  • Docker & Kubernetes
  • GraphQL & REST APIs

Compliance & Security

  • ISO 13485 quality systems
  • IEC 62304 software lifecycle
  • FDA cybersecurity framework
  • HIPAA compliance
  • Encryption & secure protocols
  • Automated testing & CI/CD

AI-Powered Development

Our AI coding agents accelerate routine development safely—not for "vibe coding", but to deliver audit‑ready quality faster than traditional methods.

  • Automated code generation with compliance checks
  • Enhanced testing and documentation
  • Human oversight ensures quality and compliance
  • 30-50% faster development cycles
50%
Faster Development
100%
Compliance Maintained
ISO
13485 Certified
24/7
Code Quality Checks

Ready to accelerate your medical device development?

Let's discuss how our integrated approach can help you build secure, compliant software faster and launch with confidence.