OBTAINING CERTIFICATION
AND PERMISSION
Obtaining ISO certification
ISO9001:2015
We have obtained international certification for the introduction of quality management systems.
ISO13485:2016
We have obtained international certification to maintain the safety and quality of medical devices.
Obtaining MDD
（Medical Device Directive）
certification
Directive 93/42/EEC
We have obtained the certification of "Medical Device Directive （MDD）", which is a basic requirement that must be met in order to legally introduce or sell medical devices in the EU.