What is ISO?

ISO stands for 'International Organization for Standardization' and is a worldwide federation of national standardization institutes (ISO members).

ISO 13485:2016 is an international standard that manufacturers, suppliers and distributors of medical devices can meet in order to demonstrate compliance with legal requirements regarding medical devices and demonstrate this to their customers. ISO 13485:2016 is a quality management system in the medical industry.

In October 2020, OptimaT recieved the ISO13485:2016 certificate for all processes in the Cleanroom.