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
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
Cybersecurity Engineering & Testing
Threat modeling (STRIDE), SBOM generation, fuzz & penetration testing, and comprehensive risk documentation led by NSA/DoD veterans.
- STRIDE threat modeling
- Penetration testing
- Software Bill of Materials (SBOM)
- Risk assessment documentation
- Post-market monitoring
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
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
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.