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<p>睡不著的看過來，很催眠的一集． <br /> <br />這集節目的內容重點可分為兩大部分 <br /><strong>學習新知識的方法</strong>與<strong>FDA</strong> <strong>CM&S(computer modeling and simulation)報告指引：</strong></p><ol><li>學習新事物的核心原則：掌握整體架構 (Input/Output)</li><li>美國 FDA 醫療器材送審：電腦建模與模擬（CM&S）報告指引</li></ol><p> <br />內容提到的兩份FDA文件： <br />Reporting Guidance (2016)：“Reporting of Computational Modeling Studies in Medical Device Submissions” <br />Credibility Guidance (2023)：“Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” <br /> <br />留言告訴我你對這一集的想法： <a href="https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments" target="_blank">https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments</a> <br /> <br /> <br />✎ 留言: <a href="https://podcast.biomeder.com/contact-us" target="_blank">podcast.biomeder.com/contact-us</a> <br />📧 Email: <a href="mailto:media@biomeder.com" target="_blank">media@biomeder.com</a> <br /> <br /> <br />《生醫人生旅歷》<a href="https://podcast.b...