Quality system

Mitsar. Co. Ltd. quality management system is certified to be in compliance with the European standard for medical devices ISO 13485:2003.

Mitsar products have been classified as Class IIb devices and are in conformity with requirements of Annex I of the European council directive 93/42/EEC and are CE marked under the supervision of Notified Body VTT.


Certificates for download


Declaration of Conformity