Summary:
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.