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”
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Information
- Show
- FrequencyUpdated weekly
- Published9 October 2025 at 16:41 UTC
- Length38 min
- Episode231
- RatingClean