Medical Grade Wearable Physiological Monitoring Solution

Medical-grade wearable physiological monitoring devices capable of continuous home-based measurement of multiple physiological parameters, over a 10–12 month longitudinal study period, including heart rate, heart rate variability, respiratory rate, skin temperature, physical activity, and sleep metrics. The devices should enable access to raw physiological signal data (e. g.

PPG, accelerometer, temperature) suitable for research analysis. The system should include a secure data transmission mechanism via a mobile application, and support integration with research data platforms through an open API or data export functionality. A web-based research portal for data management and monitoring should be provided, with an optional patient-facing interface for individual feedback and adherence tracking.

Devices must be CE-marked under the EU Medical Device Regulation (MDR 2017/745) and manufactured under ISO 13485 quality management standards. The solution should have a low maintenance requirement, an intuitive user interface, and a compact, comfortable form factor suitable for continuous daily wear.