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关注：1
2013-05-23 12:21
求翻译：Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a si是什么意思？ 待解决
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Please note that all manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a si
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2013-05-23 12:21:38
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2013-05-23 12:23:18
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2013-05-23 12:24:58
请注意: II和III设备和精选的类I设备要求所有制造商(包括规格开发商)在他们的设备的发展期间，类跟随设计控制(21 CFR 820.30)。 持有人510 (k)必须有设计控制文献可利用为粮食与药物管理局回顾在场所检查期间。 另外，必须做对设备规格或制造过程的所有变动与质量系统章程(21 CFR 820符合)并且也许是受一新510支配(k)。 当时请看我们的教导， “决定为对一个现有的设备的变动递交510 (k)
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2013-05-23 12:26:38
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2013-05-23 12:28:18
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