ISO 13485 specifies requirements for a quality management system for the design and development, manufacture and servicing of medical devices.
It can also be used to assess an organization’s ability to comply with consumer demands and regulatory requirements.
A certification body applying for ISO 13485 accreditation must comply with ISO/IEC 17021, MD9 and other additional international requirements as detailed in the Specific Accreditation Requirements for the MDQMS scheme.
MDQMS is a specific standard for the medical device industry that addresses the special needs associated with the production of a particular medical device, such as production control, quality management and compliance with regulations. The purpose of MDQMS, namely ISO 13485: 2016, is to promote harmonization and to maintain the regulatory requirements for medical devices and the requirements of quality management systems.