Posted By
Haiyan Wei
04-Jan-2023 13:13
Found In
Egroup:
Regulatory Open Forum
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Olga, If the software is required by the robotic surgery hardware device to perform its intended use, it belongs to Software in a Medical Device (not SaMD) while the robotic surgery equipment is considered as the medical device. Very often, they are referred to as Embedded Software. However, if the ...
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