What is ISO 13485

ISO 13485 is an International Standard for Effective establishment and implementation of Medical Device Quality Management Systems.

How it works

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements

Who can use

Organizations which are involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support) can go for this ISO 13485 implementation.

ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.