title: [Medical device software requirements and evaluation].
abstract: This paper introduces the safety and effectiveness requirements of medical device software. And it discusses the methods on evaluating medical device software from two aspects, the design and development process of the software and software products.
authors.affiliation: Zhejiang Institute for the Control of Medical Device, Hangzhou, Zhejiang, 310009. zjhetao@tom.com
authors.forename: Tao
authors.initials: T
authors.lastname: He
authors.forename: Yi
authors.initials: Y
authors.lastname: Wu
authors.forename: Kun
authors.initials: K
authors.lastname: Du
mesh_terms: D004869:Equipment Safety; D004864:Equipment and Supplies; D012984:Software; D012986:Software Validation