In order to get the manufacturing license, our company has passed the inspection against the Medical Device Quality Management System Regulations.
QMS, Quality Management System also known as GMP.
It is to ensure our device is able to be consistently produced and controlled by the proper quality standards.
We are the only one Taiwan company in our industry pass the QMS inspection.
ISO 13485: 2016
ISO 13485 is an international standard that specifies requirements for quality management systems for the medical device manufacturers.
The purpose is to ensure the we can provide high standards of quality assurance and product safety for our products and services, increase consumer trust and loyalty, and enhance corporate image and market competitiveness.