(如:医疗器械生产质量管理规范、美国联邦法规食品药品监督管理局-21条质量体系法规等)和适用标准(如:YY/T0287/ISO13485)要求。Review the process and software validation activities to ensure the validation processes fully comply the requirements of applicable medical device regulations (e.g., Good Manufacturing Practice for Medical Devices, 21 CFR...