Bengaluru, India – July
02, 2025 : 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 is more than a
regulatory requirement—it is a symbol of clinical trust, product maturity, and
global readiness. Building on its earlier FDA clearance, this
dual-certification reinforces Dozee’s credibility as a clinically validated,
internationally compliant solution, ready to transform care delivery across
diverse healthcare ecosystems worldwide.
“CE Mark positions Dozee among a select group
of global health-tech innovators whose solutions meet stringent international
standards while driving real-world impact.” said Gaurav Parchani, CTO
& Co-founder of Dozee. “We’re building world class infrastructure to
provide access to quality healthcare to billions globally. Every signal
captured, every insight generated, is designed to drive timely intervention and
save lives. That’s how we turn engineering into impact—by
designing systems trusted across borders, and built for humanity.”
The CE Mark opens access to
over 30 countries across the European Economic Area (EEA) and
catalyzes 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.
Dozee is transforming patient
care at scale. With a presence in 300+ hospitals and care centers across India,
the USA, Africa, and the UAE, it empowers care teams to enhance efficiency,
reduce Code Blue events, enable early intervention, reduce length of stay in
critical care, and elevate the overall patient experience—driving better
outcomes and raising the standard of care worldwide.
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.