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make_equal=&#8221;on&#8221; _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_padding=&#8221;60px||60px&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_css_main_element=&#8221;display: flex; || flex-direction: column; || justify-content: center;&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.5.3&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; header_font=&#8221;||||||||&#8221; header_text_color=&#8221;#000000&#8243; header_2_font=&#8221;||||||||&#8221; header_2_text_color=&#8221;#000000&#8243; hover_enabled=&#8221;0&#8243;]<\/p>\n<h2>\u6cd5\u89c4\u7ffb\u8bd1<\/h2>\n<p>\u4f5c\u4e3a\u5168\u7403\u76d1\u7ba1\u6700\u4e25\u683c\u7684\u884c\u4e1a\u4e4b\u4e00\uff0c\u533b\u7597\u5668\u68b0\u884c\u4e1a\uff0c\u5305\u62ec\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\uff0c\u5bf9\u4e8e\u8bbe\u5907\u7684\u5b89\u5168\u751f\u4ea7\u3001\u4f7f\u7528\u548c\u9500\u552e\u65b9\u9762\u90fd\u6709\u7740\u6781\u4e3a\u4e25\u683c\u7684\u76d1\u7ba1\u8981\u6c42\u3002\u65e0\u8bba\u662f\u5bfb\u6c42\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u4e0a\u5e02\u524d\u6279\u51c6\uff08PMA\uff09\uff0c\u8fd8\u662f\u9700\u8981\u9075\u5b88\u6b27\u76df\u7684MDR\uff0c\u76d1\u7ba1\u8fc7\u7a0b\uff0c\u90fd\u9700\u8981\u5927\u91cf\u7684\u6587\u4ef6\u548c\u7ffb\u8bd1\u6587\u4ef6\u652f\u6301\u3002\u4e3a\u4e86\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u8fc5\u901f\u901a\u8fc7\u76d1\u7ba1\u7a0b\u5e8f\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u4e3a\u6240\u6709\u7c7b\u578b\u7684\u76d1\u7ba1\u6587\u4ef6\u63d0\u4f9b\u4e00\u81f4\u548c\u53ca\u65f6\u7684\u7ffb\u8bd1\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%9b%bd%e9%99%85%e4%b8%93%e5%88%a9%e7%bf%bb%e8%af%91\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u8bbe\u5907\u4e13\u5229\u7ffb\u8bd1<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%85%e8%a3%85%e6%a0%87%e7%ad%be%e5%92%8c%e6%8f%92%e9%a1%b5%e7%bf%bb%e8%af%91\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u8bbe\u5907\u6807\u7b7e\u7ffb\u8bd1<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%a1%a3%e6%a1%88%e7%bf%bb%e8%af%91\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u6863\u6848\u7ffb\u8bd1<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/ifu%e7%bf%bb%e8%af%91\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u4f7f\u7528\u8bf4\u660e\uff08IFU\uff09\u7ffb\u8bd1<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%89%af%e5%a5%bd%e6%96%87%e6%a1%a3%e7%ae%a1%e7%90%86%e8%a7%84%e8%8c%83\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u7684GDocP\u7ffb\u8bd1<\/u><\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e9%a3%8e%e9%99%a9%e7%ae%a1%e7%90%86%e8%ae%a1%e5%88%92%ef%bc%88rmp%ef%bc%89%e7%bf%bb%e8%af%91\/\"><u>\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\u98ce\u9669\u7ba1\u7406\u8ba1\u5212\uff08RMP\uff09\u7ffb\u8bd1<\/u><\/a><\/li>\n<\/ul>\n<p>\u6b64\u5916\uff0c\u6211\u4eec\u8fd8\u4e3a\u7279\u5b9a\u673a\u6784\u7684\u63d0\u4f9b\u6cd5\u89c4\u7ffb\u8bd1\uff0c\u5305\u62ec<a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%8c%bb%e5%ad%a6%e8%bd%af%e4%bb%b6%e7%b3%bb%e7%bb%9f%e6%8c%87%e5%8d%97%e7%bf%bb%e8%af%91\/\"><u>FDA\u6307\u5357\u7ffb\u8bd1<\/u><\/a>\u3001<a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/ce%e8%ae%a4%e8%af%81%e7%bf%bb%e8%af%91\/\"><u>CE\u6807\u5fd7\u7ffb\u8bd1<\/u><\/a>\u548c<a href=\"https:\/\/lifesciences.csoftintl.com\/mdr-translations\/\"><u>\u6b27\u76dfMDR\u6587\u4ef6\u7ffb\u8bd1<\/u><\/a>\u3002<\/p>\n<p><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e7%94%9f%e5%91%bd%e7%a7%91%e5%ad%a6%e6%b3%95%e8%a7%84%e7%bf%bb%e8%af%91\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a>\u5173\u4e8e\u6211\u4eec\u6cd5\u89c4\u7ffb\u8bd1\u7684\u4fe1\u606f\u3002<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_css_main_element=&#8221;display: flex; || flex-direction: column; || justify-content: center;&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/05\/regulation-2.png&#8221; title_text=&#8221;regulation-2&#8243; _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221; width=&#8221;84%&#8221; module_alignment=&#8221;center&#8221;][\/et_pb_image][\/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_color=&#8221;#f9f9f9&#8243; custom_padding=&#8221;0|0px|0px|0px|false|false&#8221; locked=&#8221;off&#8221;][et_pb_row column_structure=&#8221;1_3,2_3&#8243; _builder_version=&#8221;3.25&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_padding=&#8221;60px|0px|60px|0px&#8221; global_module=&#8221;175790&#8243; saved_tabs=&#8221;all&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/ISO-2022-white.png&#8221; alt=&#8221;\u6570\u636e\u5b89\u5168&#8221; title_text=&#8221;ISO-2022-white&#8221; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.5.3&#8243; max_width=&#8221;100%&#8221; custom_padding=&#8221;100px||||false|false&#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 _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221;]\n\n\n<h2>\u6570\u636e\u5b89\u5168<\/h2>\n<p>\u62e5\u670920\u591a\u5e74\u533b\u5b66\u7ffb\u8bd1\u7ecf\u9a8c\u7684CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u6df1\u8c19\u6570\u636e\u5b89\u5168\u5bf9\u6211\u4eec\u5ba2\u6237\u7684\u91cd\u8981\u6027\uff0c\u5f53\u6d89\u53ca\u5230\u4fdd\u5bc6\u95ee\u9898\u65f6\uff0c\u6211\u4eec\u4ece\u4e0d\u4f1a\u6389\u4ee5\u8f7b\u5fc3\u3002\u6211\u4eec\u62e5\u6709\u5b8c\u5584\u7684\u6587\u6863\u548c\u5b8c\u5168\u53ef\u8ffd\u6eaf\u7684\u4fe1\u606f\u5b89\u5168\u653f\u7b56\u3001\u68c0\u67e5\u8868\u548c\u8d28\u91cf\u8bb0\u5f55\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u4e0e <b>ISO 27001<\/b> \u63d0\u4f9b\u7684\u6700\u4f73\u5b9e\u8df5\u65b9\u5f0f\u4fdd\u6301\u4e00\u81f4\uff0c\u4fdd\u969c\u5ba2\u6237\u4fe1\u606f\u7684\u5b89\u5168\u3002\n<\/p>\n<p><span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%8a%80%e6%9c%af%e5%ae%89%e5%85%a8\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a><\/span>\u5173\u4e8eCSOFT\u5982\u4f55\u4f18\u5148\u8003\u8651\u6570\u636e\u5b89\u5168\u7684\u4fe1\u606f\u3002\n<\/p>\n    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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