title: [Discussion on the building of post market risk analysis method in hemodialysis device].
abstract: This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.
authors.affiliation: Guangzhou Medical Instruments Quality Surveillance and Inspection Center of State Food and Drug Administration, Guangzhou. xhl-88@163.com
authors.forename: Honglei
authors.initials: H
authors.lastname: Xu
authors.forename: Xiaolong
authors.initials: X
authors.lastname: Peng
authors.forename: Xiaojun
authors.initials: X
authors.lastname: Tian
authors.forename: Peilian
authors.initials: P
authors.lastname: Wang
mesh_terms: D033161:Government Regulation; D006435:Renal Dialysis / Q000295:instrumentation* / Q000592:standards*; D012107:Research Design; D018570:Risk Assessment; D012308:Risk Management