Cortiqa Health Pvt. Ltd., an Enterprise Wellness Platform, aimed at being a key enabler of healthier lifestyles, announced today, that it has received ISO 13485:2016 certification in recognition of the compliance of the organization’s Quality Management System. The scope of certification entails design and development of In-Vitro Diagnostic Kit (IVD) including Device Accessory Part for stress level monitoring.
Cortiqa Health’s flagship product CoHeal is a non-invasive, quantitative, point-of-care testing platform.
ISO 13485 is a globally recognized Quality Management System standard for maintaining quality and compliance in the medical device industry. It is obtained from the globally acknowledged and accepted ISO 9000 QMS series. Cortiqa Health has achieved this certification by maintaining a high standard of quality at every stage of its product design and development.
“We are quality driven and have a system in place to ensure and support it. We have been able to successfully maintain the efficacy of our processes by staying focussed and working consistently towards our technology and quality goals,” says Dr. Kokila Kakhandaki, Co-Founder and Sr. Partner of Community Success at Cortiqa Health.
“With this certification, we have demonstrated commitment to the safety and quality of our medical device. I am happy to be associated with a great team at Cortiqa Health that has worked towards achieving this milestone,” she further added.
For more information, visit: www.coheal.ai