ISO 13485

ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes - is an internationally recognised standard for quality management systems in the medical device industry.

• The standard specifies requirements for a Quality Management System that can be used by organisations in the design, development and production, as well as installation and service provision of medical devices.
• The standard specifies Quality Management System requirements for organisations that need to demonstrate their ability to deliver medical devices and related services in a manner that meets customer requirements and applicable legislation.

Marketing and use of medical devices within the EU is regulated by law, hence often as part of the approval process for medical devices, legislation refers to ISO 13485 and demands compliance with its requirements, e.g. the EU Medical Devices Directive.

ISO 13485 is a stand-alone standard, providing requirements that address, among other things, production supervision, service, software validation, sterilisation validation, advisory notes, incident reporting, etc.