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1
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其他國家/組織 |
(IMDRF)Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices Key Terms and Definitions, 2021
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2
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其他國家/組織 |
MHRA Guidance: Medical Device stand-alone software including apps (including IVDMDs)
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3
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其他國家/組織 |
IMDRF/SaMD WG/N41FINAL, “Software as a Medical Device (SaMD): Clinical Evaluation”
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