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style="font-size: 16px;line-height:115%;font-family:新宋體;color:#3263BC">據(jù)國際標(biāo)準(zhǔn)化組織（ISO）官網(wǎng)最新消息，醫(yī)療器械質(zhì)量管理體系ISO 13485:2016新標(biāo)準(zhǔn)將于2016年3月1日正式發(fā)布 。</span></p><p style="margin-bottom: 13px;line-height: 115%"><span style="font-size:16px;line-height:115%;font-family:新宋體;color:#3263BC"> </span><span style="font-size: 16px;line-height:115%;font-family:新宋體;color:#3263BC">同時(shí)，歐洲標(biāo)準(zhǔn)化委員會(huì)（CEN ）將于2016年3月2日發(fā)布最新EN版 ISO 13485。</span></p><p style="margin-bottom: 13px;line-height: 115%"><span style="font-size:16px;line-height:115%;font-family:新宋體;color:#3263BC">ISO 13485:2016</span><span style="font-size:16px;line-height:115%;font-family:新宋體;color:#3263BC">新標(biāo)準(zhǔn)引入和強(qiáng)化了大量醫(yī)療器械行業(yè)最佳實(shí)踐。兼容了包括美國 FDA QSR 820、日本J-Pal法規(guī)169、巴西GMP 、歐盟MDR & IVDR 、加拿大、澳大利亞和中國 CFDA 《質(zhì)量管理規(guī)范》等國家醫(yī)療器械法規(guī)的要求。此外，新版將體系和法規(guī)監(jiān)管以及產(chǎn)品注冊(cè)更好的結(jié)合，可幫助企業(yè)提升自主研發(fā)能力，提高企業(yè)的競爭能力。 </span></p><p 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