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. 

Pune is emerging as a major medical device manufacturing hub in India, with a number of companies operating in the region. The city’s favorable business environment, skilled workforce, and access to capital make it an attractive destination for medical device manufacturers. With the Indian government’s push to promote domestic manufacturing and reduce dependence on imports, Pune is expected to play a key role in the growth of the medical device industry in India.