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國內外智慧醫材法規文件
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The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, 2022
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(FDA)Good Machine Learning Practice for Medical Device Development Guiding Principles,2021
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(FDA)Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, 2017
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Developing a Software Precertification Program: A Working Model, 2019
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Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities, 2019.
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“Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD)-Discussion Paper and Request for Feedback”, 2019.
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Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, 2012
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Clinical Decision Support Software, 2022
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(FDA)Proposed Regulatory Framework for Modifications to Artificial Intelligence Machine Learning-Based Software as a Medical Device (SaMD), 2021
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Software as a Medical Device (SAMD): Clinical Evaluation, 2017
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