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Bengaluru-based digital healthcare platform Dozee, a fast-growing player in Remote Patient Monitoring (RPM) and Early Warning Systems (EWS), has secured a major global milestone: CE Mark under the European Union’s Medical Device Regulation (EU MDR 2017/745).
This milestone underscores Dozee’s steadfast commitment to clinical safety, product excellence, and world-class regulatory compliance, affirming that clinically-validated innovations from India can set the benchmark on the global stage.
The CE Mark opens access to over 30 countries across the European Economic Area (EEA) and catalyses Dozee’s vision to make continuous, remote patient monitoring and early warning systems a global standard.
Dozee’s vital signs monitoring system, classified as Class IIb under MDR, measures and monitors vital signs such as: Heart Rate(HR), Respiration Rate(RR), Non-invasive Blood Pressure, Temperature, Oxygen Saturation (SpO₂) and Patient Movement. These are tracked seamlessly using contactless sensors and advanced algorithms, enabling healthcare providers to detect early signs of patient deterioration, intervene in time, and significantly improve clinical outcomes.
The CE Mark was awarded by TÜV SÜD, a globally respected Notified Body, after comprehensive assessments of Dozee’s quality management system, technical documentation, and clinical validation. It attests to the solution’s robustness in real-world settings and its readiness to support healthcare systems across care settings around the world.
In 2022, Dozee received US-FDA 510(k) clearance for its proprietary contactless vital signs (VS) monitoring technology. With the CE Mark, Dozee is set to strengthen the global infrastructure for connected, AI-powered healthcare.
