(AmeliaxYuchin) 嗨,你在開發產品嗎?跟上生醫開發的浪潮，這幾年生技/醫療科技展，好多IoT和網路科技的醫療應用產品啊?這些產品是醫療器材嗎?要申請FDA許可嗎?沒有接觸過生醫產業，真的搞不清楚!!無論你是研發工程師、產品經理、新創公司創辦人..，這集很建議聽喔!不要興高采烈地產品做好了，才發現整個方向都不對，申請FDA許可好多困難。單集內容👉https://podcast.biomeder.com/episodes/medical-product-need-to-fda-approval/ (00:01:45) 我的產品需不需要送FDA申請?要怎麼看? (00:04:05) 確定屬於醫療器材，怎麼知道屬於什麼等級呢? (00:12:47) 真的要送FDA申請許可，那要送什麼資料過去? (00:20:22) 常見的例子。 (00:49:09) 總結。 留言告訴我你對這一集的想法： https://open.firstory.me/story/ckxgb7ih10lk90817oeta5nvc?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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