精选优质文档- 倾情为你奉上 专心-专注-专业 上市后临床跟踪控制程序 文件编号： QP-29 版本：A/0 生效日期： 页码： 17 编制： 审核： 批准： 1. PURPOSE The purpose of this work instruction is to define the process to determine and document whether a post-market clinical follow-up study is required forTDI Foot/Ankle Array 8ch medical devices bearing the CE mark. The process will lead to a determination of whether a post-market clinical follow-up study is required and provide guidance for post-market clinical monitoring requirements if a study is not requir
