[Research on quality system management of software manufacturers for medical devices].
Based on the investigation and analysis of the current situation of medical devices' software manufacturers an exploration of new administrative modalities for the enterprises is presented in the paper.
Zheng
Jian-gong
JG
Safety Control Department for Medical Devices, Shanghai Food and Drug Administration.
Xu
Yan-nuo
YN
D004864:Equipment and Supplies / Q000592:standards*; D007221:Industry / Q000458:organization & administration; D011786:Quality Control; D012985:Software Design