What is the ISO 13485 medical device system?

The new ISO 13485:2016 standard was officially released on March 1, 2016. The new ISO 13485:2016 standard introduces and enhances a large number of medical device industry best practices. It is compatible with the requirements of national medical device regulations including US FDA QSR 820, EU MDR & IVDR and China CFDA Code of Quality Management.

ISO 13485, the Quality Management System for Medical Devices, is the standard most adhered to by medical device manufacturers worldwide. This standard is developed on the basis of ISO 9001, with the addition of special requirements for the medical device industry, to support and help some companies that manufacture or use medical products and services to reduce unforeseen risks, and play a good role in promoting the quality of medical devices to achieve safety and effectiveness.

The main feature of the ISO13485:2016 standard is that ISO13485 is an independent standard, not a guideline for the implementation of the ISO9001 standard in the medical device industry, and the two are not compatible.