ISO 13485:2016

An international standard that outlines the requirements for a quality management system specific to the medical device industry. 

ISO 13485 focuses on ensuring product quality through risk management, company processes, regulatory compliance, and maintaining effective product processes for the safe design, manufacture, and distribution of medical devices. 

It is applicable to organizations regardless of their size or type, except where explicitly stated, and provides a framework for implementing regulatory and quality management system requirements globally.