The second station of The FDAQSR820 and factory inspection strategies senior seminar " in Shanghai was open up in the Great Wall plaza holiday hotel. on December 4 to 6.
We invite Tim, previous FDA medical equipment supervision and management director, as the experts, and Mike Gu, general manager of O***unda Medical Device C***ulting Organization and the domestic regulati*** experts, as the site translator. We analyze the devepolopment of medical device combining the key problem of FDA fed back by domestic enterprise and recent trend of FDA review. The topics focous on the FDA QSR820 quality management system, QSIT quality inspection technology, how to prepare FDA factory inspection and shareFDA factory inspection experience, etc.
The FDA QSR820 and factory inspection strategies senior seminar class attracted many large-scale medical equipment enterprise. The student has a warm resp***e and g***e high evaluation of experts for the wonderful lecture. Enterprise participated includemany large medical device enterprises: industry-clustering Medical treatment, "fisher's new industry, biological, MaiLang (Shanghai) Medical treatment, ELEKTA Medical, camel people Medical device, KeHui, PSS in the United States, Wallace KeWei enterprise, bo fe Medica enterprise.