VMPL
Bengaluru (Karnataka) [India], July 2: 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 complianceaffirming that clinically-validated innovations from India can set the benchmark on the global stage.
The CE Mark is more than a regulatory requirementit 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 impactby 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 systemclassified as Class IIb under MDRmeasures 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 TUV SUD, 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 experiencedriving 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.
For Media Queries, Please contact:
Ms. Pratha Bhagat
+91 7378781427
Pratha@dozee.io
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