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