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|| flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/05\/regulation-2.png” alt=”Pharmaceuticals require expert translations” title_text=”regulation-2″ align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”80%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”18px” custom_margin=”||29px|5px”]<\/p>\n \u6b63\u5982\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u8981\u6c42\u53d8\u5f97\u66f4\u52a0\u4e25\u683c\u4e00\u6837\uff0c\u6709\u5173MDR\u7ffb\u8bd1\u7684\u8981\u6c42\u4e5f\u662f\u5982\u6b64\u3002\u6240\u6709\u9700\u8981\u4e0a\u4f20\u5230EUDAMED\u6570\u636e\u5e93\u7684\u533b\u7597\u6570\u636e\u90fd\u5fc5\u987b\u8fdb\u884c\u7ffb\u8bd1\uff0c\u5e76\u4e14\u80fd\u591f\u63d0\u4f9b24\u79cd\u6b27\u76df\u5b98\u65b9\u8bed\u8a00\u7684\u7ffb\u8bd1\u7248\u672c\u3002\u51ed\u501f\u6211\u4eec\u4e13\u4e1a\u7684\u5168\u7403\u6bcd\u8bed\u8bd1\u5458\u548c\u533b\u5b66\u4e3b\u9898\u4e13\u5bb6\u7f51\u7edc\u3001\u5148\u8fdb\u7684\u8bed\u8a00\u6280\u672f\u548c\u672c\u5730\u5316\u7684\u6700\u4f73\u5b9e\u8df5\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u80fd\u591f\u5e2e\u52a9\u4e3a\u533b\u7597\u5668\u68b0\u516c\u53f8\u5b9e\u73b0\u8de8\u8bed\u8a00\u7684\u6b27\u76df\u5e02\u573a\u51c6\u5165\u3002<\/p>\n \u4e86\u89e3\u66f4\u591a<\/u><\/a>\u5173\u4e8e\u6211\u4eecMDR\u7ffb\u8bd1\u3002<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px” border_width_top=”1px” border_color_top=”#cccccc” saved_tabs=”all”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n\n\n\n \u901a\u8fc7\u6211\u4eec\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 \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\u8bed\u8a00\u9a8c\u8bc1<\/u><\/a><\/span>\u3001\u56de\u8bd1<\/u><\/a><\/span>\u548c\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\u4e86ISO 17100:2015\u3001ISO 9001:2015<\/b><\/strong>\u548cISO 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\u5408ISO 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>\nCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u5982\u4f55\u9ad8\u6548\u7f16\u5199\u548c\u7ffb\u8bd1SSCP\uff1a<\/h3>\n
\n
\u533b\u7597\u8bbe\u5907\u7ffb\u8bd1<\/h2>\n
\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u7ffb\u8bd1<\/h2>\n
\u8d28\u91cf\u4fdd\u8bc1<\/h2>\n\n