{"id":165275,"date":"2017-11-10T02:34:03","date_gmt":"2017-11-10T02:34:03","guid":{"rendered":"https:\/\/www.csoftintl.com\/quanqiuhua\/regulatory-submissions-language-requirements\/"},"modified":"2022-03-10T06:53:24","modified_gmt":"2022-03-10T06:53:24","slug":"faguishenchatijiao","status":"publish","type":"page","link":"https:\/\/www.csoftintl.com\/cn\/quanqiuhua\/faguishenchatijiao\/","title":{"rendered":"\u4e3a\u6cd5\u89c4\u5ba1\u67e5\u63d0\u4ea4\u8fdb\u884c\u89c4\u5212"},"content":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1510283148889{background-image: url(https:\/\/www.csoftintl.com\/wp-content\/uploads\/2017\/11\/regulatory-services.jpg?id=123859) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221; el_class=&#8221;header-hero&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_column_text css_animation=&#8221;none&#8221;]<\/p>\n<h1 class=\"hero-tit\" style=\"text-align: center;\">\u4e3a\u6cd5\u89c4\u5ba1\u67e5\u63d0\u4ea4\u8fdb\u884c\u89c4\u5212<\/h1>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;40px&#8221; el_class=&#8221;hidden-xs hidden-sm&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;bg-60&#8243;][vc_column][vc_row_inner][vc_column_inner]<style>#breadcrumb-69efd48874eaf li::after { content: \"\u00bb\" }<\/style><ol class=\"wwp-vc-breadcrumbs \" id=\"breadcrumb-69efd48874eaf\"><li class=\"visited\"><a href=\"\/\">Home<\/a><\/li><li class=\"visited\"><a href=\"https:\/\/www.csoftintl.com\/cn\/quanqiuhua\/\">\u5168\u7403\u5316<\/a><\/li><li class=\"current\"><span>\u4e3a\u6cd5\u89c4\u5ba1\u67e5\u63d0\u4ea4\u8fdb\u884c\u89c4\u5212<\/span><\/li><\/ol>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/6&#8243;][vc_raw_html]JTNDc3R5bGUlM0UlMEEuYmlnZ2VyJTIwJTdCZm9udC1zaXplJTNBJTIwMS40ZW0lM0IlMjBsaW5lLWhlaWdodCUzQSUyMDEuNmVtJTNCJTdEJTBBJTNDJTJGc3R5bGUlM0U=[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1510283580486{padding-top: 30px !important;}&#8221;][vc_column_text el_class=&#8221;bigger&#8221; css=&#8221;.vc_custom_1540451239186{margin-top: 50px !important;margin-bottom: 40px !important;}&#8221;]\u5728\u4eca\u5929\u8fd9\u4e2a\u9ad8\u5ea6\u5168\u7403\u5316\u7684\u4e16\u754c\u91cc\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u516c\u53f8\u6b63\u5728\u5bfb\u627e\u65b0\u5174\u5e02\u573a\u4ee5\u6269\u5927\u589e\u957f\u3002\u8ba9\u6211\u4eec\u5e2e\u52a9\u60a8\u6ee1\u8db3\u76d1\u7ba1\u90e8\u95e8\u7684\u8bed\u8a00\u8981\u6c42\uff0c\u4ee5\u987a\u5229\u8fdb\u5165\u65b0\u5e02\u573a\u3002[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/6&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzZXBhcmF0b3IlMjIlM0UlM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1505799807690{padding-top: 50px !important;padding-bottom: 50px !important;}&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;5\/12&#8243;][vc_column_text]<img class=\"size-full wp-image-855 aligncenter\" src=\"\/wp-content\/uploads\/2017\/11\/regulatory-img01.png\" alt=\"\">[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;7\/12&#8243; css=&#8221;.vc_custom_1510294909131{padding-top: 30px !important;}&#8221;][vc_column_text]\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7684\u76d1\u7ba1\u63d0\u4ea4\u9700\u8981\u5411\u76d1\u7ba1\u673a\u6784\u63d0\u4ea4\u5927\u91cf\u590d\u6742\u7684\u6587\u4ef6\u3002\u63d0\u4ea4\u7684\u6587\u4ef6\u5fc5\u987b\u4ee5\u7eb8\u8d28\u6216\u7535\u5b50\u683c\u5f0f\u63d0\u4ea4\uff0c\u6216\u4e24\u8005\u7ed3\u5408\u3002\u7531\u4e8e\u6587\u4ef6\u91cf\u5927\uff0c\u76d1\u7ba1\u673a\u6784\u901a\u5e38\u4f1a\u9f13\u52b1\u7535\u5b50\u63d0\u4ea4\uff0c\u4f8b\u5982\u836f\u54c1\u7684eCTD\uff0c\u6240\u9700\u7684\u6587\u4ef6\u6570\u91cf\u4e5f\u5c06\u56e0\u6d89\u53ca\u7684\u76d1\u7ba1\u673a\u6784\u800c\u5f02\u3002[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1510647072955{background-color: #f9f9f9 !important;}&#8221; el_class=&#8221;pv-row-sm&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/6&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text]<br \/>\n\u9700\u8981\u7ffb\u8bd1\u7684\u76d1\u7ba1\u6587\u4ef6\u5305\u62ec\uff1a<\/p>\n<ul class=\"superiority \">\n<li class=\"col-md-6\">IFU<\/li>\n<li class=\"col-md-6\">CMC\u6587\u4ef6<\/li>\n<li class=\"col-md-6\">&gt;\u75c5\u4f8b\u62a5\u544a\u8868<\/li>\n<li class=\"col-md-6\">\u534f\u8bae\u4e66<\/li>\n<li class=\"col-md-6\">\u751f\u4ea7\u7a0b\u5e8f<\/li>\n<li class=\"col-md-6\">\u8bbe\u8ba1\u89c4\u8303<\/li>\n<li class=\"col-md-6\">\u98ce\u9669\u8bc4\u4f30<\/li>\n<li class=\"col-md-6\">\u751f\u7269\u76f8\u5bb9\u6027\u62a5\u544a<\/li>\n<li class=\"col-md-6\">\u4e34\u5e8a\u8bd5\u9a8c\u6587\u4ef6<\/li>\n<li class=\"col-md-6\">\u77e5\u60c5\u540c\u610f\u4e66<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/6&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1510647083392{background-color: #0093f8 !important;}&#8221; el_class=&#8221;pv-row-sm&#8221;][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column width=&#8221;10\/12&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_column_text css=&#8221;.vc_custom_1510292039564{padding-top: 30px !important;}&#8221;]<img class=\"size-full wp-image-855 aligncenter\" src=\"\/wp-content\/uploads\/2017\/11\/regulatory-img03.png\" alt=\"\">[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1505985113618{padding-top: 60px !important;padding-bottom: 60px !important;}&#8221;][vc_column_text]<\/p>\n<p class=\"white\">CSOFT\u56fd\u9645\u62e5\u6709\u4e00\u4e2a\u7531\u4e13\u4e1a\u7684\u8bed\u8a00\u5b66\u5bb6\u3001\u6587\u5316\u4e13\u5bb6\u548c\u8bed\u8a00\u6280\u672f\u56e2\u961f\u7ec4\u6210\u768410,000+\u4eba\u7684\u5168\u7403\u7f51\u7edc\uff0c\u4ece\u800c\u4e3a\u76d1\u7ba1\u6587\u4ef6\u63d0\u4f9b\u4e13\u4e1a\u7684\u672c\u5730\u5316\u89e3\u51b3\u65b9\u6848\uff0c\u5e2e\u52a9\u9886\u5148\u7684\u5236\u836f\u548c\u533b\u7597\u8bbe\u5907\u516c\u53f8\u8282\u7701\u65f6\u95f4\u548c\u524a\u51cf\u6210\u672c\u3002<\/p>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<p class=\"white\">\u65e0\u8bba\u662f\u6280\u672f\u7ffb\u8bd1\u3001\u8425\u9500\u7ffb\u8bd1\uff0c\u8fd8\u662f\u5168\u7403\u5316\u54a8\u8be2\uff0c\u6211\u4eec\u90fd\u4e86\u89e3\u751f\u547d\u79d1\u5b66\u884c\u4e1a\uff0c\u4ee5\u53ca\u5982\u4f55\u5e2e\u52a9\u5176\u63a8\u52a8\u5168\u7403\u5e02\u573a\u7684\u589e\u957f\u3002<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1510291914244{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221; el_class=&#8221;bg-80&#8243;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;.vc_custom_1542351216182{margin-bottom: 40px !important;}&#8221;]<img class=\"size-full wp-image-855 aligncenter\" src=\"\/wp-content\/uploads\/2017\/11\/regulatory-img04.png\" alt=\"\">[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text]\u51ed\u501f\u591a\u5e74\u7684\u884c\u4e1a\u7ecf\u9a8c\uff0c\u6211\u4eec\u4e3a\u7528\u6237\u624b\u518c\u3001\u53c2\u8003\u8d44\u6599\u3001\u4e34\u5e8a\u7814\u7a76\u534f\u8bae\u3001\u5e02\u573a\u5ba3\u4f20\u6587\u4ef6\u7b49\u63d0\u4f9b\u51c6\u786e\u7684\u7ffb\u8bd1\uff0c\u53ef\u4ee5\u5e2e\u52a9\u60a8\u4ee5\u66f4\u5feb\u7684\u901f\u5ea6\u3001\u66f4\u9ad8\u7684\u6210\u672c\u6548\u76ca\u3001\u66f4\u597d\u7684\u8d28\u91cf\u548c\u843d\u5730\u76d1\u7ba1\u6587\u4ef6\u3002[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1510282388932{background-color: #d3eeff !important;}&#8221; el_class=&#8221;bg-80&#8243;][vc_column][vc_row_inner][vc_column_inner width=&#8221;4\/12&#8243;][vc_column_text]<img class=\"alignnone size-full wp-image-862\" src=\"\/wp-content\/uploads\/2017\/11\/regulatory-img06.png\" alt=\"\">[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;8\/12&#8243;][vc_column_text]\u5728CSOFT\u534e\u4e5f\u56fd\u9645\uff0c\u6211\u4eec\u5efa\u8bae\u5ba2\u6237\u5728\u6bcf\u4e2a\u9879\u76ee\u751f\u4ea7\u4e4b\u524d\u5148\u8fdb\u884c\u98ce\u9669\u5206\u6790\u3002\u6211\u4eec\u4f7f\u7528\u884c\u4e1a\u6807\u51c6\u6d41\u7a0b\uff0c\u540c\u65f6\u4e5f\u4e3a\u6bcf\u4e2a\u5ba2\u6237\u63d0\u4f9b\u7075\u6d3b\u6027\uff0c\u4e0d\u7ba1\u8fc7\u7a0b\u9700\u8981\u4ec0\u4e48\uff0c\u90fd\u5c3d\u529b\u5e2e\u52a9\u4ed6\u4eec\u7684\u516c\u53f8\u83b7\u5f97\u6210\u529f\u3002<\/p>\n<p>\u4e0b\u8f7d\u6211\u4eec\u5173\u4e8e\u7ffb\u8bd1\u8d28\u91cf\u7684\u6700\u65b0\u767d\u76ae\u4e66\uff0c\u4e86\u89e3\u4e3a\u4ec0\u4e48\u8bed\u8a00\u670d\u52a1\u63d0\u4f9b\u5546\u7684\u8d28\u91cf\u4e0d\u4e00\u6837\u3002[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;bg-80-0&#8243;][vc_column][vc_row_inner][vc_column_inner][vc_column_text]\n\n\n <div class=\"row\">\n          <div class=\"col-md-5 text-center pt\"><img width=\"400\" class=\"alignnone size-full wp-image-998 pt-xl\" src=\"https:\/\/www.csoftintl.com\/wp-content\/uploads\/2022\/03\/ISO-2022.png\" alt=\"Quality Assurance\"><\/div>\n\n         <div class=\"col-md-7\">\n        \n         \n\t\t\t    \n         <h2>\u8d28\u91cf\u6807\u51c6<\/h2>\n        <p>\n        \u4f5c\u4e3a\u4e00\u5bb6\u901a\u8fc7<b>ISO 17100:2015<\/b>\u3001<b>ISO 9001:2015<\/b>\u548c<b>ISO 13485:2016<\/b>\u8ba4\u8bc1\u7684\u516c\u53f8\uff0c CSOFT\u534e\u4e5f\u56fd\u9645\u7684\u7ffb\u8bd1\u6d41\u7a0b\u5305\u62ec\u591a\u8f6e\u6821\u5ba1\uff0c\u9075\u5faa\u98ce\u683c\u6307\u5357\uff0c\u4f7f\u7528\u5177\u6709\u81f3\u5c117\u5e74\u7ecf\u9a8c\u7684\u4e3b\u9898\u4e13\u5bb6\uff08SME\uff09\u548c\u8bed\u8a00\u5b66\u5bb6\u3002\u51ed\u501f20\u591a\u5e74\u7684\u884c\u4e1a\u7ecf\u9a8c\uff0c\u6211\u4eec\u5df2\u7ecf\u5f00\u53d1\u51fa\u6210\u719f\u7684\u7ffb\u8bd1\u3001\u7f16\u8f91\u3001\u6821\u5bf9\uff08TEP\uff09\u4ee5\u53ca\u9879\u76ee\u7ba1\u7406\u6d41\u7a0b\u3002\n        <\/p>\n        <p><a href=\"https:\/\/www.csoftintl.com\/cn\/bendihua\/zhiliangbaozheng\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a><\/p>\n        <\/div>\n    <\/div>\n\n    [\/vc_column_text][vc_column_text][\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJzZXBhcmF0b3IlMjIlM0UlM0MlMkZkaXYlM0U=[\/vc_raw_html][\/vc_column][\/vc_row][vc_row el_class=&#8221;bg-80-0&#8243;][vc_column][vc_row_inner][vc_column_inner][vc_column_text]\n    \n    \n      <div class=\"row\">\n      <div class=\"col-md-2\"><\/div>\n         <div class=\"col-md-8 contact-box  pt-xxl pb-xxl text-center\">\n         <div class=\"wpb_wrapper\">\n           <div class=\"vc_empty_space hidden-xs hidden-sm\" style=\"height: 10px\"><span class=\"vc_empty_space_inner\"><\/span><\/div>\n\t\t\t<h2>\u5373\u523b\u8054\u7cfb CSOFT \u534e\u4e5f\u56fd\u9645<\/h2>\n<p>\u8be6\u7ec6\u4e86\u89e3 CSOFT \u5c06\u5982\u4f55\u6ee1\u8db3\u60a8\u7684<a href=\"\/cn\/bendihua\/fanyifuwu\/\">\u7ffb\u8bd1\u9700\u6c42<\/a> \uff0c\u8bf7\u62e8\u6253 CSOFT \u534e\u4e5f\u56fd\u9645\u4e9a\u6d32\u529e\u516c\u5ba4\u8054\u7cfb\u7535\u8bdd <a href=\"tel:+861057366000\">+86-10-5736-6000<\/a>\u3002\u60a8\u4e5f\u53ef\u4ee5<a href=\"\/cn\/lianxiwomen\/\">\u70b9\u51fb\u6b64\u5904<\/a>\uff0c\u53d1\u9001\u6587\u4ef6\u7ed9\u6211\u4eec\u4ee5\u83b7\u53d6\u62a5\u4ef7\u4fe1\u606f\u3002<\/p>\n<p>\u60a8\u8fd8\u53ef\u4ee5<a href=\"\/cn\/rfp\/\">\u70b9\u51fb\u6b64\u5904\u53d1\u9001\u62db\u6807\u6587\u4ef6\u81f3 CSOFT \u534e\u4e5f\u56fd\u9645<\/a> \uff0c\u6211\u4eec\u5c06\u6839\u636e\u9879\u76ee\u9700\u6c42\u4e3a\u60a8\u6253\u9020\u4e2a\u6027\u5316\u7684\u7ffb\u8bd1\u670d\u52a1\u3002<\/p>\n\n\t\t<\/div>\n<\/div>\n\n    <\/div><!--row end-->\n    \n    \n    [\/vc_column_text][vc_column_text][\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]<\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4e3a\u6cd5\u89c4\u5ba1\u67e5\u63d0\u4ea4\u8fdb\u884c\u89c4\u5212 JTNDc3R5bGUlM0UlMEEuYmlnZ2VyJTIwJTdCZm9udC1zaXplJTNBJTIwMS40ZW0lM0Il &#8230;<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":128967,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"pgc_sgb_lightbox_settings":""},"_links":{"self":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/pages\/165275"}],"collection":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/comments?post=165275"}],"version-history":[{"count":13,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/pages\/165275\/revisions"}],"predecessor-version":[{"id":165289,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/pages\/165275\/revisions\/165289"}],"up":[{"embeddable":true,"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/pages\/128967"}],"wp:attachment":[{"href":"https:\/\/www.csoftintl.com\/cn\/wp-json\/wp\/v2\/media?parent=165275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}