EP239-強調「探索」而非稽核,FDA MDDAP的實質效益與職涯機會 episode artwork

EPISODE · Dec 24, 2025 · 56 MIN

EP239-強調「探索」而非稽核,FDA MDDAP的實質效益與職涯機會

from 生醫人生旅歷 · host BioMeder

這集來賓: 王誠 Chen, MDDAP Appraisal Team Lead MDDAP(Medical Device Discovery Appraisal Program)是 US FDA 在2023年9月正式公佈的自願改進計劃(Voluntary Improvement Program, VIP)。上一集我們了解什麼是MDDAP,這一集來聊到底為什麼參加這個program?又是如何能成為MDDAP的評鑑員呢? 這集你可以聽到: 1.MDDAP appraisal例子? 2.導入有什麼實質幫助?現實面(FDA提供的獎勵)和自我提升;會不會影響FDA真正來做audit的成績? 3.醫材公司要如何能加入MDDAP/VIP計畫呢?費用?時程? 4.如何成為appraisal team member/lead? 如果還沒有聽過上一集,建議先聽上一集。 本集參考連結: Webinar: The Voluntary Improvement Program: How to Enroll, Opportunities and Best Practices (https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-voluntary-improvement-program-how-enroll-opportunities-and-best-practices-10082024)  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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EP239-強調「探索」而非稽核,FDA MDDAP的實質效益與職涯機會

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