ISO 13485 is a quality system standard designed specifically for medical device companies. The ISO13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices.

The quality management system requirements specified in the ISO 13485 standard complementstechnical requirements for products. The primary purpose of the ISO 13485 standard is to facilitate harmonized medical device regulatory requirements for quality systems.