The standard contains requirements for the quality management system of medical device manufacturers. The requirements for the quality management system established in the standard are additional in relation to the technical requirements for products.”
The main feature of the ISO 13485 standard is that it contains high requirements for the safety of manufactured products.
As a result, on December 31, 2020, the company received the ISO 13485:2016 standard.“ISO 13485 is an international industry standard developed by the International Organization for Standardization.
All Ibtech devices have been certified by SGS, an independent Swiss company providing services for independent examination, control, testing and certification of production and products.