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並前往https://asiaactual.com/wp-content/uploads/2022/07/Guidelines-for-Medical-Device-Software-Registration-Review-2022-Revised-Edition-English.docx

Guidelines-for-Medical-Device-Software-Registration-Review ...

Standalone software (SaMD) refers to software that has one or more medical ... [ 68 ] IMDRF/ SaMD WG/N10 FINAL: 2013 , SaMD: Key Definitions [Z] , 2013.12.

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