Healthcare & Medical Devices
HIPAA-Compliant Encrypted Medical IoT Gateway
Vitalis BioHealth Solutions · 18 weeks — design, firmware & FDA pre-cert
The challenge
Legacy patient monitoring systems suffered from high latency, frequent WiFi dropouts in hospitals, and vulnerability to network-level interception.
The solution
An ISO 13485-compliant Raspberry Pi Compute Module 4 carrier board with an integrated ATECC608A cryptographic secure element and dual-SIM LTE fallback.
Architecture highlights
- Hardware root of trust with secure boot and encrypted flash storage
- Zero-trust BLE medical peripheral pairing with certificate exchange
- Real-time cardiac arrhythmia detection on local ARM Cortex cores
- FDA 510(k) cybersecurity guidance clearance on the first submission
“The engineering craftsmanship was unprecedented. Their team understood both the silicon constraints and strict FDA regulatory compliance effortlessly.”