title: [Research on quality system management of software manufacturers for medical devices].
abstract: 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.
authors.affiliation: Safety Control Department for Medical Devices, Shanghai Food and Drug Administration.
authors.forename: Jian-gong
authors.initials: JG
authors.lastname: Zheng
authors.forename: Yan-nuo
authors.initials: YN
authors.lastname: Xu
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D007221:Industry / Q000458:organization & administration; D011786:Quality Control; D012985:Software Design