average time for medical device products - MedicalDevice版 - 未名存档

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MedicalDevice版 - average time for medical device products

相关主题
● Human Factors	● IDE
● PMA	● quality system regulations (GMP for device)
● 美国公司中国分部的研发的 classIII 产品	● 俺也来帮斑竹添砖---IDE (investigational device exempt)
● FDA Regulation of Medical Devices	● The Medical Device Industry’s Biggest Challenge: Innovation or Taxes? zz
● 太尉给讲讲 personal mobile medical device	● FDA Modernization Act of 1997
● 什么样的医疗器械是国内没得的	● the Medical Device Innovation Initiative by FDA
● 学术第一贴 - 美国器械分类.	● medical device - by wiki
● 学术第二贴 - CDRH	● GAO renews critique of FDA medical device system

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话题: device话题: products话题: average话题: medical话题: time

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b***p 发帖数: 1398	1 anybody would like to give an estimation or examples on average time (from proposal to launch) for medical device products from class I to class III?
k****i 发帖数: 1126	2 这个范围太大了吧。基本上如果是class III,好几年是肯定的，因为要做IDE，如果是classII，走510k的话，现在光FDA审批这步就比以前慢了很多，半年到一年都有可能。之前的研发时间也就根据不同产品不一样的。【在 b***p 的大作中提到】 : anybody would like to give an estimation or examples on average time (from : proposal to launch) for medical device products from class I to class III?
b***p 发帖数: 1398	3 even class I here takes 1-2 year; it seems R&D engineers need more projects to fill their working time

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相关主题
● GAO renews critique of FDA medical device system	● 太尉给讲讲 personal mobile medical device
● Is Statistician needed in Medical Device Company?	● 什么样的医疗器械是国内没得的
● 求：关于医疗器械方面的杂志	● 学术第一贴 - 美国器械分类.
● ISO 13485	● 学术第二贴 - CDRH
● Human Factors	● IDE
● PMA	● quality system regulations (GMP for device)
● 美国公司中国分部的研发的 classIII 产品	● 俺也来帮斑竹添砖---IDE (investigational device exempt)
● FDA Regulation of Medical Devices	● The Medical Device Industry’s Biggest Challenge: Innovation or Taxes? zz

相关话题的讨论汇总
话题: device话题: products话题: average话题: medical话题: time

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