In 1998, we got the certificate of ISO9002 & EN46002 from TUV Product Service GmBH, Germany, a well- known Notify Body in the world. In 2004, we received the certificate of ISO13488 & EC 93/42EEC. In 2005 we passed the audit of ISO13485:2003, a professional requirement for medical devices. Meanwhile, we also passed the FDA factory audit.