The Development of Software as a Medical Device (SaMD) -Clarification of Clinical Significance-

Clarification of clinical significance is very important in the development of SaMDs (Software as a Medical Device) that have become active in recent years.
This whitepaper summarizes the items that should be considered when clarifying the clinical significance based on the “Guidelines of Determining Whether Software is Classified as a Medical Device” issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan in 2021.

The Development of Software as a Medical Device (SaMD) – Clarification of Clinical Significance –