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ISO13485認(rèn)證流程 ISO13485是適用于醫(yī)療器械法規(guī)環(huán)境下的質(zhì)量管理體系標(biāo)準(zhǔn)，其全稱是《醫(yī)療器械質(zhì)量管理體系用于法規(guī)的要求》。1996年ISO13485首次發(fā)布，2003年ISO/TC210發(fā)布了ISO13485：2003，應(yīng)用于醫(yī)療器械領(lǐng)域。2015年ISO/TC210再次修訂ISO13485，2016年3月ISO13485:2016正式發(fā)布。 Time:2018-6-29 11:32:54 View:1811

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