Process Validation and Revalidation in Medical Device Production. (2017)

• Record Type: Journal Article
• Authors: Zhao, Yincheng; Sheng, Kuangjie; Wang, Zheng; Zhang, Xilin; HengyiYang, ; Miao, Rui
• Is Part Of: Procedia engineering. Volume 174(2017)
• Page Start: 686
• Page End: 692
• Publication Date: 2017
• Subjects: Process Validation -- Minitab -- Design of Experiment; Engineering -- Congresses; Engineering -- Periodicals; Engineering; Conference proceedings; Periodicals; 620.005
• DOI: 10.1016/j.proeng.2017.01.207
• Languages: English
• ISSNs: 1877-7058

Abstract

Abstract: In this paper, the author according to ISO13485:2003, YY / T 0287-2003 quality management system for medical device regulatory requirements, and process validation guidance document GHTF-SG3-N99-10-2004, combined with the actual implementation process in the enterprise, detailed the process and applications of process validation. Then share some the statistical methods of data collection and analysis, describe how to do Design of Experiment experiments by Minitab software.