title: [Comparison of the software safety evaluation methods in medical devices].
abstract: The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe.
authors.affiliation: Medical Device Registration Department, Shanghai Municipal Food and Drug Administration, Shanghai, 200010. yusicong@smda.gov.cn
authors.forename: Sicong
authors.initials: S
authors.lastname: Yu
authors.forename: Ying
authors.initials: Y
authors.lastname: Pan
authors.forename: Xiping
authors.initials: X
authors.lastname: Yu
authors.forename: Yinfeng
authors.initials: Y
authors.lastname: Zhu
mesh_terms: D002681:China; D004869:Equipment Safety / Q000379:methods*; D005060:Europe; D011786:Quality Control; D017751:Safety Management / Q000379:methods*; D012984:Software; D014481:United States