ISO 13485 was revised in 2016 and medical device manufacturers have three years to transition to the new standard or risk losing certification. The deadline for the ISO 13485:2016 transition period is 28 February 2019.
ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. These organisations can be involved in all stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. ISO 13485 can also be used by suppliers or external parties that provide product to such organisations.