Time:
2017
-
06
-
09
ISO 13485, also known as 'Medical Device Quality Management System' in Chinese, is a special product for saving lives, helping injuries, and preventing and treating diseases. It is not enough to standardize medical devices solely according to the general requirements of the ISO9000 standard. Therefore, the ISO organization has issued the ISO 13485-1996 version standards (YY/T0287 and YY/T0288), which put forward special requirements for the quality management system of medical device man...