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並前往https://www.cocir.org/fileadmin/Position_Papers_2020/COCIR_Analysis_on_AI_in_medical_Device_Legislation_-_Sept._2020_-_Final_2.pdf

EU MEDICAL DEVICE LEGISLATION - COCIR

Figure 9 Classification Rule 11§1 is based on the IMDRF SaMD risk framework. ... IMDRF N10 Software as a Medical Device (SaMD): Key Definitions.

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