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生醫人生旅歷

EP187-ASME V&V 40,醫療器材適用,真的不是Garbage in , Garbage Out...

22 Nov 2024

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ASME V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices 醫療器材開發,在減少動物實驗這個方向,電腦模擬計算也是一個重要角色。 然而,過去大家還是比較習慣做實驗,因此對於數值計算,常有懷疑的態度,畢竟太虛幻,能信嗎? 電腦模擬計算的結果,最常被人質疑,就是這些數據只是Garbage in, Garbage out? 真的就不是啊!!那就拿出證明出來... 簡單來說,在醫材產品開發的過程中,以電腦模擬產出了結果,我們該怎麼說明這個模擬的結果,是可以相信的呢? 這集是聽了會睡著的內容.. 睡不著一定要點進來聽 有緣自然會聽到後面 如果有人留言或者回饋,我們再來製作續集 也就是怎麼執行Credibility和依照指引產出FDA期待的報告 這集的重點: 1.Context of Use(COU) 2.Model Risk 3.Credibility 留言告訴我你對這一集的想法: https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments 開頭&結尾音樂: Laid Back Ukulele Reggae - 30 sec edit Music by Jerome Chauvel from Pixabay ✎ 留言: podcast.biomeder.com/contact-us 📧 Email: [email protected] 💰 小額支持: biomeder.com/product/pay-to-recognition 《生醫人生旅歷》podcast.biomeder.com   《BioMeder生醫人網摘》biomeder.com 這個節目,由生醫人文化科技製作播出。 Powered by Firstory Hosting

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