Abstract：This article introduced the functions, use mode, and design principles of digital therapy. From the perspective of
classification and definition, it is clear which conditions digital therapy products meet belong to medical devices. Quality evaluation
is carried out from three aspects: identity testing, strength configuration testing, and safety testing. Compliance criteria are proposed
for the three quality evaluation methods, and detailed explanations are provided by way of examples, Quality evaluation methods can
basically ensure the safety and effectiveness of products. With the development of technology and in-depth research, the methods
need to be further improved and improved.
王晨希，李澍，李佳戈. 数字疗法产品质量评价探讨[J]. 中国医疗设备, 2023, 38(4): 25-30.
WANG Chenxi, LI Shu, LI Jiage. Discussion on Quality Evaluation of Digital Therapeutics Products. China Medical Devices, 2023, 38(4): 25-30.
