Dozee recognised with ISO 13485:2016 certification for its Quality Management Systems


BENGALURU, India, June 1, 2022 /PRNewswire/ — Underlining the advancements that it is driving in the medical devices sector, Dozee,  India’s First Contactless Remote Health Monitoring Company, has recently received the ISO 13485:2016 certification from Intertek for its Quality Management System (QMS).

ISO 13485:2016 is an internationally recognised quality standard for enterprises in the medical device industry that comprises strict standards for quality management systems. The Company’s Quality Management System conforms to the recognised International Standard for the design and development, manufacture, distribution, installation, and service of medical devices. Intertek India Private Limited is a NABCB accredited body.

“We are delighted to have been recognised with the ISO 13485:2016 certification. ISO 13485:2016 is the most widely accepted certification in the medical devices industry for quality management systems. The certificate recognises and validates Dozee’s commitment to driving efficiency in the healthcare ecosystem by implementing contactless patient monitoring devices across public and private hospitals, further alleviating the burden on the healthcare workforce. Receiving this certification strengthens our position in the market and will also aid Dozee in its global expansion while ensuring that product and service quality continues to remain an integral part of Dozee’s strategic focus,” said Mudit Dandwate, CEO & co-founder – Dozee.

Gaurav Parchani, CTO & co-founder – Dozee, said, “Gaining ISO 13485:2016 reinforces Dozee’s relentless focus on creating industry-leading medical products, measured against global benchmarks of industry excellence.The 13485 compliance quality management system provides a systematic process and documented evidences based framework for delivering safe and effective products and solutions.This certification marks a major milestone for Dozee and supports the long-term product development strategy for the global medical and healthcare sector.”

This certification is a part of the quality journey with ISO/IEC 27001:2013  Information Security Management achieved in December 2021

. The 13485:2016 certificate enables Dozee’s roadmap for regulatory compliance in major international markets. .

Dozee previously rolled out the MillionICU initiative with the goal of enabling public hospitals to tide over the COVID-19 crisis in the short term and bring about a rapid, long-term transformation in India’s public healthcare infrastructure. Through this initiative, Dozee is set to install 50,000 step-down ICU beds across India over the next 12 months and take it to 1 million in the next 3 years. The initiative has benefited 40+ public hospitals across 20 districts in India, with more than 30,000 patients being monitored and saving 65,000+ nursing hours.

About Dozee

Dozee is India’s First Contactless Remote Health Monitoring company that tracks heart health, respiration, sleep quality and stress levels with medical grade accuracy as compared to medical devices. Dozee’s Advanced Health Intelligence, detects early signs of health deterioration by continuously assessing user’s vitals data and conducting a risk analysis. Dozee was started in October 2015 by IIT graduates Mudit Dandwate and Gaurav Parchani and has till date raised over INR 139 crore. Launched in July 2019, they have been awarded grants by the GoI’s BIRAC, Sine IIT Bombay, ACT and Bill & Melinda Gates Foundation. The start-up has also filed several patents on detecting and predicting respiratory, cardiac & neurological patterns & providing in-depth analysis of vital signals for early warning of health deterioration. For more details, please visit: https://www.dozee.health/

 

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