ISO 13485 is the most widely used international standard for quality management specifically designed for the medical device industry. It outlines the requirements for a comprehensive quality management system that ensures the safety, effectiveness, and regulatory compliance of medical devices. 

The medical device industry in Chennai is rapidly growing, with a number of companies operating in the region. With the increasing demand for medical devices in India and the government’s push to promote domestic manufacturing, Chennai is becoming an important destination for medical device companies. However, with the growing industry comes the need for regulatory compliance. The city’s favorable business environment, skilled workforce, and access to capital make it an attractive destination for medical device manufacturers.