Real-time Intelligence
Secure connectivity for a medical-grade ECG device
Client: DHeart
Overview
DHeart developed a portable, medical-grade ECG device designed for home use. The device needed to transmit sensitive clinical data to a cloud platform for AI-assisted analysis, while meeting strict medical regulatory requirements (MDR, GDPR) and ensuring data integrity from device to dashboard.
The Challenge
The key challenge was balancing usability for non-technical patients with the security and reliability requirements of a Class IIa medical device. Connectivity had to work over Bluetooth and Wi-Fi, data had to be encrypted end-to-end, and the system needed to handle offline scenarios where patients might not have internet access during recording.
Our Solution
Ermit designed the full connectivity stack: a BLE/Wi-Fi bridge on the device, a companion app SDK for patient onboarding and data sync, and a secure cloud ingestion layer with end-to-end encryption. The architecture included store-and-forward capabilities for offline resilience and automated certificate management for device identity.
Results
The device is now in active use across multiple European markets. Data transmission is fully encrypted and auditable, meeting MDR and GDPR requirements. The companion app reduced setup errors and support calls significantly.