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並前往https://www.morganlewis.com/news/2021/11/fdas-samd-simd-guidance-could-mean-documentation-headaches-for-some-software-makers-attorney-says-medtech-insight

FDA's SaMD/SiMD Guidance Could Mean ... - Morgan Lewis

A long-awaited draft guidance from the US Food and Drug Administration (FDA) delineates which medical software devices will need additional ...

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