What is ISO 13485?

ISO 13485 Definition

International Organization for Standardization defined ISO 13485 for companies involved in the design, production, installation, and servicing of medical devices and related services. ISO 13485 can also be used by internal and external parties, such as certification bodies, to help with auditing processes. ISO 13485 compliance occurs when impacted organizations can demonstrate that their quality management system (QMS) follows regulatory best practices throughout a product’s lifecycle from creation through service and delivery of medical devices that are safe and effective for their intended purpose. ISO 13485:2016 was published in March of 2016 and is the latest version of ISO 13485 as of March 25, 2021.