ISO 13485, the quality management system standard for medical devices, has been put on the table to be updated since 2010. The standard has now been updated. For the revision of ISO 13485 standard 2016, public opinion surveys on the whole world were added to the new version by gathering expert and user comments.

The revision of the ISO 13485 standard for 2016 has also taken on the role of a guide from 2003 onwards to make it compatible with the European Directives and other international legislation for manufacturers of medical devices (including freight production).