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並前往https://journal.emwa.org/artificial-intelligence-and-digital-health/what-medical-writers-need-to-know-about-regulatory-approval-of-mobile-health-and-digital-healthcare-devices/article/5259/what-medical-writers-need-to-know.pdf

Medical Writing

medical device (SaMD) by the International. Medical Device Regulators Forum ... Definitions • EU MDR 2017/745 • IMDRF/SaMD WG/N10: 2013.

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