Process Validation and Revalidation in Medical Device Production

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.