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國內外智慧醫材法規文件
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Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff, 2018
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Postmarket Management of Cybersecurity in Medical Devices, 2016
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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2014
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General Principles of Software Validation: Guidance for Industry and FDA Staff, 2002.
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(EU)General leaflet ATI Policy Brief reports, 2021
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(EU)Advanced technology landscape and related policies in China, 2021
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(EU)proposal-for-a-regulation-laying-down-harmonised-rules-on-artificial-intelligence-impact-on-the-healthcare-sector-and-the-medical-device-industry, 2021
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(EU)Advanced Technologies for Industry – Product Watch_Artificial Intelligence-based software as a medical device, 2020
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(EU)Guidlines on the Quilification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Deivces, 2020
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