Abstract：Objective To introduce the current testing methods of software as a medical device, and to provide suggestions and ideas for better quality evaluation of such software. Methods By interpreting the technical requirements for the registration and examination of medical device software as stated in Guiding Principles which promulgated by the National Medical Products Administration, and combining with practical inspection experience, the general requirements, quality requirements and special requirements of medical device software were analyzed respectively. The elements of general requirements need to be clarificated, methods and perspectives of establishing test cases for quality requirements, and the application of special requirements were provided. Results The compilation of relevant test cases establishment of detection model and corresponding detection methods could guide manufacturers to compile the technology of medical devices software, and guide the inspection institutions to carry out relevant evaluation. Conclusion Clear product quality evaluation methods and relevant detection models can complete the detection of such products, and put forward opinions and suggestions on the shortcomings of current detection methods.
王晨希，王权，李佳戈. 医疗器械独立软件检测要求及方法[J]. 中国医疗设备, 2020, 35(11): 66-69.
WANG Chenxi, WANG Quan, LI Jiage. Requirements and Methods for Testing of Software As a Medical Device. China Medical Devices, 2020, 35(11): 66-69.
