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 Kolkata is a growing sector, with a number of companies operating in the region. The industry spans across various sectors, including diagnostic equipment, medical implants, surgical instruments, and more. Kolkata’s favorable business environment, skilled workforce, and low cost of living make it an attractive destination for medical device companies looking to establish a presence in the region. Despite the challenges posed by the COVID-19 pandemic, the medical device industry in Kolkata is expected to continue to grow in the coming years.