Tianjin UWell established Quality Management System (QMS) following ISO 13485 since the beginning phase of company founded in Sep., 2015. 
The whole device R&D process are managed by our QMS since the beginning phase. After the first samples available, our team gone through the whole verification and validation process, the pilot running process and other QMS processes.
The training of ISO 13485 was lasted for more than half year in evening after work and covered all our team member to ensure that quality will be built in everyone.
We selected TUV Rheiland as our QMS and CE certificate Third Party and the plant welcomed the first certificate auditing in Aug., 2016.
With the result of only two minor deviations, we passed the auditing by TUV Rheiland and got the Certificate of ISO 13485 and CE in Sep., 2016.