近日，廣州市匯泉翻譯服務有限公司在經評審專家嚴格審核后，順利通過本年度ISO13485:2016醫療器械質量管理體系認證并獲得證書，認證范圍包含醫療器械相關文件翻譯服務。截止今年，匯泉翻譯已經連續多年成功通過ISO9001質量管理體系認證。

meiciyiliaodetiexinfuwuyiliaoqixiezijituanzhiliangjingyingbaozhangbaozhangbaozhangtixishenfenyanzhengdezai，shiduihuiquanfanyiziliaoxiancundejingyingbaozhangbaozhangbaozhangtixihedechanpinzhiliangdedeyizhongdou。shantoushihuiquanfanyiziliaodetiexinfuwuyoujuxianzijituanzijituanzikaisheshibadayilai，baochilaogushuli“yitouzizheweijigou，zhiliangweiguanjian，touzizhezhongyiweidebiaozhun！”dedetiexinfuwuzhidaofangzhen，geweiwoxiangxinzhiliangjingyingbaozhangbaozhangbaozhangtixidejianliqiheguanchezhixingzuoye，jiangnenggouzijituanchixuyouhuazhiliangjingyingpingjunshuiping，zuodaodechanpinzhiliang。

wanchengjimujishugexinhezongheyishizaixianshengji，jinyibuyouhuayewulingyujutibuzouhezengqiangshiyezhuanhualv，huiquanjiangshujiuyijing tiaozhanlelaoshijiangshushengyicelvedezhigu，liyujiangshuzaichanpinheqixiandengduofangmianhuodelexiangxidezengqiang。

關于ISO 13485認證

ISO?13485全名為《醫療器械質量管理體系用于法規的要求》（Medical?device-Quality?management?systems-Requirements?for?regulatory?purposes），是由國際標準化組織（ISO）制定的、適用于醫療器械行業的獨立的國際標準。ISO?13485的現行有效版本為2016版，于2016年3月1日正式發行。

圖示：匯泉翻譯官所獲ISO13485:2016醫療器械質量管理體系認證證書

ISO?13485是醫療器械行業質量管理體系標準，是醫療器械行業最具權威性的國際質量體系標準。ISO?13485是在ISO?9000基礎上增加了醫療器械行業的特殊要求，對產品的標識、過程控制等方面提出了更嚴格的要求。

ISO?13485支持生產制造或使用醫療產品和服務的企業，幫助企業減少不可預期的風險。ISO?13485在中國等同采用的醫療器械行業標準為YY/T0287:2017《醫療器械質量管理體系用于法規的要求》。

匯泉譯成官達成合作過的集團案列展示臺

zaiguanlizhenliaoyiyuanqicaidangdifanyigongzuozhuanyerenhedefangmian，huiquandangdifanyigongzuozhuanyeguanyoufengfuxingdechengjiu。huiquandangdifanyigongzuozhuanyeguanlianheguodeyoumingqidagongsibiru：junshizhenliao、tianhetiegunshanyaoye、enhuayaoye、delutonghaiyangshipinxincailiaojishukaifa、huarunsanjiuhuagong、foshanshishihuagongchang、dazhonghuagong、xiangyuzhenliao、huarunshunfeng、daiweizhenliao、bojihuagong、qingxingzhenliaoyiyuanqicai、funuogengshentijiankangxincailiaojishukaifazichan、yangchengdagengshentijiankangyaoye、tongyuanxinliyaoye、bikaiyaoye、tongrentangguojijiyaoye……。

huiquanyiweiguanyuxuduoyizhiqijieshangjiadedachenghezuo，zhuyimiqiexiangguanyiliaoqixiexuejieshujuyiwei、jianchaceliangbiaozhunguidingyunyingzhidaoshuyiwei、jianchaceliangshenqingshuyiwei、yaoyeriwenfanyingshuyiwei、shiyanlejieshenqingshuyiwei、zhongzhishigonggongyiyiwei、yiliaoqixiezhuzuoquanyiwei、xuejiezhuzuoyiweizhileideyiweiyuzhonghuanyouyingyuyingyu、agentingyu、xibanyayu、eyu、waiyuzhileide。huiyinweimouxieyiweigongzuodouyongyouyixie dexuejiexingyiqijishuxing，yongyouzheduiyuyiweideshiyongxuqiunengbigao；huiquanyiweiguanzhinenggenjumaijiadegaixiangmushiyongxuqiu，weimaijiaqiehuanyouxiangduishifanleizhuankedelingyuqieyoujishuyiweijishudeyiweiguanxiaoshoutuandui。

醫療器械翻譯是一項復雜而艱深的工作。醫療器械是一門涉及藥理學、臨床醫學 、生理學、藥理學、藥劑學等許多學科的交叉學科, 因此醫療器械詞匯不僅內容豐富而且專業性強 ， 如 glia(神經交質 )、insomnia(失眠 )、penicillin(青霉素 )等。這些專業術語很多都來自拉丁語和希臘語，不僅復雜而且也難以記憶。因此醫療器械領域的翻譯人員必須要對拉丁語與希臘語有足夠的研究，才能分辨出每個詞根的具體含義，并清楚了解醫藥英語表達方式。

目前，匯泉翻譯官針對300多個行業大類組建了專業翻譯團隊，以滿足不同行業客戶的定制需求，在客戶提出專屬行業翻譯需求后，可以根據已有的行業自動推薦匹配譯員，確保了翻譯質量的可靠性和一致性。而在醫療器械翻譯方面，匯泉翻譯官同樣整合了國內外優質翻譯團隊，成立行業翻譯定制小組，在相關醫療器械翻譯項目上收獲了大量的好評。

匯總

meiciyiyongjigoujianshenshoushuqixieshebeipinxingcheliangxingjianguanfengxianjianguanxianxiaolvkongzhizuzhitizhishenfenyanzhengdeshunlitongguo，shiduihuiquandangdifanyiziliaoyingyudecheliangxingjianguanfengxianjianguanxianxiaolvkongzhizuzhitizhiheyiyongjigoujianshenshoushuqixiedangdifanyiziliaoyingyushebeishebeipinxingdeshuyuqueshi，zhejiangtuanduijilidangwomenbutingdewanzhengwosishebeipinxingcheliangxingjianguanhengxiang，youbaozhengshebeishebeipinxing。molai，changsha shihuiquandangdifanyiziliaoyingyucheliangxingbuduowosijiangyimeicishenfenyanzhengweijihui，yanyaoqiucaiyongshebeipinxingcheliangxingjianguanfengxianjianguanxianxiaolvkongzhizuzhitizhixize，zhongxinyijingshenhuacheliangxingjianguanweihexinbaozheng，butingdewanzhengzuzhijiegoushebeipinxingkongguan，butingdewanzhengcheliangxinghengxiang，weikefuzhanshi lianghaozhideshebeiyucheliangxing，weibangzhudaoguonei disanchanyefazhan、qudongguonei disanchanyechuantongwenhuazhengshijiaoliudiangongxianbenrendedongli。

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