With the continuous progress of technology and the development of the medical field,the functions of medical device software products are becoming increasingly rich and complex,and higher requirements are also put forward for the review of medical device software.This article summarizes and analyzes the requirements for traceability analysis in the"Guidelines for Medical Device Software Registration Review"(revised in 2022),the"Guidelines for the on-site Inspection of Independent Software Site of Medical Device Production Quality Management Specification",and the"Appendix of Independent Software of Medical Device Production Quality Management Specification",summarizes and analyzes the requirements for traceability analysis of medical device software products,and provides some technical review and system verification points and suggestions.The key points of traceability analysis were ultimately proposed,providing reference and inspiration for how to conduct software traceability analysis in the technical evaluation and system verification of medical device software.
medical softwaretraceability analysistechnical evaluationsystem verification
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