ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) in the medical device industry. It is designed to help organizations demonstrate their ability to manufacture medical devices and perform related services that consistently meet customer and regulatory requirements. The standard addresses the design, development, production, installation, and servicing of medical devices and related services. It is intended to be used by organizations regardless of their size or type, and it is suitable for use by both manufacturers and suppliers of medical devices. The standard is also aligned with other international standards such as ISO 9001, and it can be used in conjunction with regulatory requirements for medical devices.