What is ISO 13485 standard?

ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) is an internationally recognized standard that addresses the development, implementation and maintenance of a quality management system in the medical device industry. It specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices, and that related services in the life cycle of medical devices, consistently meet customer requirements and applicable regulatory requirements. The relevant life cycle can include design, production, installation, servicing and sales of medical devices.