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align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243; max_width=&#8221;87%&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;off|off|off&#8221; module_class=&#8221;check-list-box&#8221; _builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; header_font=&#8221;||||||||&#8221; header_3_text_align=&#8221;center&#8221; hover_enabled=&#8221;0&#8243;]<\/p>\n<h2>\u653f\u5e9c\u53e3\u8bd1\u7ffb\u8bd1<\/h2>\n<p>\u968f\u7740\u4e16\u754c\u4eba\u53e3\u7684\u65e5\u76ca\u8054\u901a\uff0c\u653f\u5e9c\u673a\u6784\u9700\u8981\u51c6\u786e\u7684\u53e3\u8bd1\u89e3\u51b3\u65b9\u6848\u6765\u53c2\u52a0\u4f1a\u8bae\u3001\u7b79\u6b3e\u6d3b\u52a8\u548c\u5176\u4ed6\u5730\u65b9\u3001\u5dde\u548c\u8054\u90a6\u653f\u5e9c\u804c\u80fd\u3002\u6b64\u5916\uff0c\u53e3\u8bd1\u533b\u5b66\u5185\u5bb9\u5bf9\u4e8e\u6210\u529f\u4e3e\u529e\u4e0e\u76d1\u7ba1\u673a\u6784\uff08\u5982pre-IND\/NDA\u4f1a\u8bae\uff09\u76f8\u5173\u7684\u533b\u5b66\u4f1a\u8bae\u548c\u4f1a\u8bae\u4e5f\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002\u6b64\u5916\uff0c\u4e3a\u907f\u514d\u6b67\u89c6\u6027\u8bc9\u8bbc\uff0c\u7f8e\u56fd\u8bb8\u591a\u653f\u5e9c\u673a\u6784\u88ab\u8981\u6c42\u4e3a\u82f1\u8bed\u80fd\u529b\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u8bed\u8a00\u670d\u52a1\u3002CSOFT \u534e\u4e5f\u751f\u547d\u79d1\u5b66\u4e3a\u653f\u5e9c\u673a\u6784\u3001\u975e\u653f\u5e9c\u7ec4\u7ec7\u3001\u516c\u5171\u90e8\u95e8\u516c\u53f8\u548c\u5176\u4ed6\u56fd\u9645\u7ec4\u7ec7\u63d0\u4f9b\u8d85\u8fc7250\u79cd\u8bed\u8a00\u7684\u73b0\u573a\u548c\u8fdc\u7a0b\u53e3\u8bd1\u670d\u52a1\u3002<\/p>\n<p><a href=\"\/zh-hans\/\u653f\u5e9c\u673a\u6784\u548c\u975e\u8425\u5229\u6027\u7ec4\u7ec7\u7684\u53e3\u8bd1\u670d\u52a1\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a>\u5173\u4e8e\u6211\u4eec\u4e3a\u653f\u5e9c\u673a\u6784\u63d0\u4f9b\u7684\u53e3\u8bd1\u670d\u52a1\u3002<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.5.3&#8243; background_enable_color=&#8221;off&#8221; custom_padding=&#8221;0px|0px|0px|0px|false|false&#8221; global_module=&#8221;174958&#8243; saved_tabs=&#8221;all&#8221; locked=&#8221;off&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.5.3&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_padding=&#8221;60px||60px&#8221; border_width_top=&#8221;1px&#8221; border_color_top=&#8221;#eeeeee&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_code _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221;]\n\n\n<h2>\u8d28\u91cf\u4fdd\u8bc1<\/h2>\n\n<p>\u901a\u8fc7\u6211\u4eec<span><a href=\"https:\/\/www.csoftintl.com\/technology\/\"><u>\u57fa\u4e8e\u4e91\u7684\u521b\u65b0\u6280\u672f<\/u><\/a><\/span>\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5728\u7ebf\u7ffb\u8bd1\u7ba1\u7406\u751f\u6001\u7cfb\u7edf\uff0c\u7cfb\u7edf\u4e2d\u5fc3\u4f4d\u7f6e\u5b9e\u65f6\u5229\u7528\u7ffb\u8bd1\u8bb0\u5fc6\u4ee5\u53ca\u672f\u8bed\u7ba1\u7406\u3002<\/p>\n\n<p>\u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u548c\u672c\u5730\u5316\u4e1a\u52a1\u5bf9\u653f\u5e9c\u673a\u6784\u6781\u4e3a\u91cd\u8981 - \u4e0d\u51c6\u786e\u7684\u7ffb\u8bd1\u4e0d\u4ec5\u4f1a\u5bfc\u81f4\u65f6\u95f4\u3001\u6210\u672c\u548c\u7cbe\u529b\u7684\u6d6a\u8d39\uff0c\u800c\u4e14\u8fd8\u4f1a\u5f71\u54cd\u60a3\u8005\u548c\u6d88\u8d39\u8005\u7684\u751f\u6d3b\u3002\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u81f4\u529b\u4e8e\u786e\u4fdd\u6700\u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u670d\u52a1\u3002\u4e3a\u6b64\uff0c\u6211\u4eec\u8058\u8bf7\u81f3\u5c11\u67097\u5e74\u7ecf\u9a8c\u7684\u672c\u571f\u8bed\u8a00\u5b66\u5bb6\uff0c\u5e76\u4e14\u4e0d\u65ad\u62d3\u5c55\u6211\u4eec\u7684\u591a\u9886\u57df\u4e3b\u9898\u4e13\u5bb6\u7f51\u7edc\u3002\u6b64\u5916\uff0c\u6211\u4eec\u901a\u8fc7<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%af%ad%e8%a8%80%e9%aa%8c%e8%af%81\/\"><u>\u8bed\u8a00\u9a8c\u8bc1<\/u><\/a><\/span>\u3001<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%9b%9e%e8%af%91\/\"><u>\u56de\u8bd1<\/u><\/a><\/span>\u548c<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/gestion-terminologica\/\"><u>\u672f\u8bed\u7ba1\u7406<\/u><\/a><\/span>\u4e0d\u65ad\u5b8c\u5584\u672c\u5730\u5316\u6700\u4f73\u5b9e\u8df5\uff0c\u5e2e\u52a9\u653f\u5e9c\u673a\u6784\u3001\u975e\u653f\u5e9c\u7ec4\u7ec7\u3001\u516c\u5171\u90e8\u95e8\u548c\u56fd\u9645\u7ec4\u7ec7\u63a5\u89e6\u4e0d\u540c\u6587\u5316\u80cc\u666f\u7684\u793e\u533a\u3002\u4e3a\u4e86\u786e\u4fdd\u9ad8\u8d28\u91cf\u7684\u6280\u672f\u7ffb\u8bd1\u89e3\u51b3\u65b9\u6848\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u7684\u4e13\u4e1a\u6027\u5f97\u5230\u4e86<strong><b>ISO 17100:2015\u3001ISO 9001:2015<\/b><\/strong>\u548c<strong><b>ISO 13485:2016<\/b><\/strong>\u8ba4\u8bc1\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u652f\u6301\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u7b26\u5408<strong><b>ISO 27001<\/b><\/strong>\u7684\u6700\u4f73\u5b9e\u8df5\uff0c\u786e\u4fdd\u6211\u4eec\u7684\u5b9a\u5236\u5316\u89e3\u51b3\u65b9\u6848\u7b26\u5408\u5168\u7403\u76d1\u7ba1\u8981\u6c42\u3002\n<\/p>\n<p><span><a href=\"https:\/\/lifesciences.csoftintl.com\/translation-quality\/\"><u>\u9605\u8bfb\u66f4\u591a<\/u><\/a><\/span>\u5173\u4e8e\u6211\u4eec\u7684\u8d28\u91cf\u4fdd\u8bc1\u3002<\/p>\n\n\n    [\/et_pb_code][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; 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