(ft. 劉珏珊 Sandy老師 - 珊學社FDAclass 創辦人暨執行長)美國醫療器材申請到底在做什麼?什麼樣的狀況需要申請呢?還有，以後有人跟你說這個產品拿到美國FDA認證，不要隨便相信，是假的?根本沒有這樣的事.. 單集內容👉https://podcast.biomeder.com/episodes/us-medical-device-application (00:01:25)美國醫療器材法規申請， 到底在做什麼? (00:05:23)如果標示獲得美國FDA上市許可呢?(是什麼意思) (00:08:39)申請流程要多久? (00:13:07)申請案預留時間和準備程度 (00:14:59)申請中最困難的是什麼? (00:19:31)台灣廠商最常見的問題是..? (00:26:42)顧問案中有趣的例子 (00:36:44)和美國FDA溝通的趣事 (00:47:58)FDA查廠用意簡述 留言告訴我你對這一集的想法： https://open.firstory.me/story/ckv1uot9qoadb0991d5fix8l1?m=comment ✎ 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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