{"id":175224,"date":"2021-02-24T20:30:53","date_gmt":"2021-02-25T03:30:53","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/?page_id=175224"},"modified":"2022-03-02T01:52:42","modified_gmt":"2022-03-02T08:52:42","slug":"ce%e8%ae%a4%e8%af%81%e7%bf%bb%e8%af%91","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/ce%e8%ae%a4%e8%af%81%e7%bf%bb%e8%af%91\/","title":{"rendered":"CE\u8ba4\u8bc1\u7ffb\u8bd1"},"content":{"rendered":"
[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2017\/10\/pills_on_a_table.jpg”][et_pb_fullwidth_header button_one_text=”\u7acb\u5373\u8054\u7cfb\u6211\u4eec” button_one_url=”https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%81%94%e7%b3%bb\/” background_overlay_color=”rgba(0,15,28,0.35)” content_max_width=”67%” _builder_version=”3.20.2″ content_font_size=”20px” subhead_font=”||on||||||” subhead_font_size=”20px” background_color=”rgba(0,39,183,0.36)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/02\/ce-translation1.jpg” background_position=”top_right” custom_padding=”80px||100px” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”]<\/p>\n
\u6211\u4eec\u4e3a\u8bd5\u56fe\u5728\u6b27\u6d32\u5730\u533a\u53d1\u5c55\u7684\u751f\u547d\u79d1\u5b66\u516c\u53f8\u63d0\u4f9b\u9ad8\u8d28\u91cf\u7684\u6280\u672f\u6587\u4ef6\u7ffb\u8bd1\u670d\u52a1\uff0c\u4ee5\u83b7\u5f97CE\u6807\u5fd7[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_position=”center_right” custom_padding=”60px|0px|0px|0px|false|false”][et_pb_row make_equal=”on” _builder_version=”3.25″ background_color=”rgba(255,255,255,0)” background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”||30px” border_radii=”on|5px|5px|5px|5px” border_width_bottom=”1px” border_color_bottom=”#ccc”][et_pb_column type=”4_4″ _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=”3.27.4″ text_font=”||||||||” text_font_size=”18px” custom_margin=”||29px|5px”]CE\u6807\u5fd7\uff0c\u6709\u65f6\u4e5f\u88ab\u79f0\u4e3aCE\u8ba4\u8bc1\u6216\u6b27\u6d32\u8d38\u6613\u62a4\u7167\uff0c\u6807\u5fd7\u7740\u4ea7\u54c1\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u7b26\u5408\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08EEA\uff09\u5173\u4e8e\u516c\u5171\u5065\u5eb7\u548c\u5b89\u5168\u7684\u6d88\u8d39\u8005\u548c\u73af\u5883\u4fdd\u62a4\u6807\u51c6\u3002CE\u6807\u5fd7\u4e00\u8bcd\u5728\u6cd5\u8bed\u4e2d\u4ee3\u8868 “Conformit\u00e9 Europ\u00e9ene”\uff0c\u7ffb\u8bd1\u4e3a\u6b27\u6d32\u7b26\u5408\u6027\u3002\u6b27\u6d32\u7ecf\u6d4e\u533a\u753127\u4e2a\u6b27\u76df\u6210\u5458\u56fd\u4ee5\u53ca\u51b0\u5c9b\u3001\u5217\u652f\u6566\u58eb\u767b\u548c\u632a\u5a01\u7ec4\u6210\uff0c\u8fd9\u4f7f\u5f97CE\u6807\u5fd7\u5bf9\u4e8e\u6240\u6709\u8bd5\u56fe\u5728\u4e00\u4e2a\u6781\u5176\u591a\u6837\u5316\u7684\u5e02\u573a\u4e0a\u5236\u9020\u3001\u9500\u552e\u6216\u751f\u4ea7\u7684\u4ea7\u54c1\u6765\u8bf4\u90fd\u662f\u5fc5\u4e0d\u53ef\u5c11\u7684\u3002\u867d\u7136CE\u6807\u5fd7\u4e0d\u662f\u4e00\u4e2a\u8d28\u91cf\u4fdd\u8bc1\u7684\u6b65\u9aa4\uff0c\u4f46\u5b83\u662f\u4e00\u4e2a\u5f3a\u5236\u6027\u7684\u5b89\u5168\u6807\u5fd7\uff0c\u8868\u660e\u7b26\u5408\u6307\u4ee4\u7684\u8981\u6c42\u3002<\/p>\n
\u65b0\u7684\u6b27\u76dfMDR\u7684\u5b9e\u65bd\u4e5f\u5f71\u54cd\u4e86CE\u6807\u5fd7\u7ffb\u8bd1\u8981\u6c42\u7684\u53d8\u5316\u3002\u4ee5\u524d\uff0c\u9700\u8981CE\u6807\u5fd7\u7684\u6280\u672f\u6587\u4ef6<\/u><\/a>\u4e0d\u9700\u8981\u8fdb\u884c\u7ffb\u8bd1\u9884\u5ba1\u3002\u7136\u800c\uff0c\u6839\u636eMDR\u7684\u8981\u6c42\uff0c\u83b7\u5f97CE\u6807\u5fd7\u7684\u6587\u4ef6\uff0c\u5982\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e\uff08IFU\uff09<\/u><\/a>\u548c\u60a3\u8005\u4fe1\u606f\u6587\u4ef6<\/u><\/a>\uff0c\u5fc5\u987b\u7ffb\u8bd1\u6210\u6bcf\u4e2a\u56fd\u5bb6\u7684\u5b98\u65b9\u8bed\u8a00\u3002\u6b64\u5916\uff0c\u5404\u56fd\u53ef\u4ee5\u4e3a\u56fd\u5185\u4e0d\u540c\u4eba\u7fa4\u6307\u5b9a\u6240\u9700\u7684\u5176\u4ed6\u8bed\u8a00\u3002\u5728\u6240\u6709\u5b98\u65b9\u8bed\u8a00\u4e2d\uff0c”\u6e05\u6670\u548c\u51c6\u786e “\u7684\u7ffb\u8bd1\u662f\u5fc5\u8981\u7684\uff0c\u4ee5\u786e\u4fdd\u65e0\u8bba\u8c01\u5728\u9605\u8bfb\u6750\u6599\uff0c\u90fd\u80fd\u5b8c\u5168\u548c\u6709\u6548\u5730\u7406\u89e3\u5185\u5bb9\u3002\u5bf9\u4e8e\u672a\u80fd\u9075\u5b88CE\u6807\u5fd7\u7684\u516c\u53f8\u6765\u8bf4\uff0c\u8fd9\u53ef\u80fd\u4f1a\u9020\u6210\u5f53\u5730\u76d1\u7ba1\u673a\u6784\u7684\u6f5c\u5728\u8c03\u67e5\uff0c\u5bfc\u81f4\u751f\u4ea7\u65f6\u95f4\u8868\u7684\u5ef6\u8bef\uff0c\u5e76\u6700\u7ec8\u5f71\u54cd\u6536\u5165\u3002[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_class=”bg-blue-dark” _builder_version=”3.22″ background_position=”center_right” custom_padding=”60px|0px|66.1875px|0px|false|false”][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” _builder_version=”3.25″ background_color=”rgba(255,255,255,0)” background_size=”initial” background_position=”top_left” background_repeat=”repeat” border_radii=”on|5px|5px|5px|5px”][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=”3.27.4″ text_font=”||||||||” text_text_color=”#ffffff” text_font_size=”18px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#ffffff” custom_margin=”||29px|5px”]<\/p>\n \u5305\u62ec\u4ece\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0<\/u><\/a>\u5230\u4e3b\u52a8\u690d\u5165\u5f0f\u533b\u7597\u5668\u68b0\uff0cCE\u6807\u5fd7\u662f\u6240\u6709\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u5e76\u7b26\u5408\u5f53\u5730\u76d1\u7ba1\u8981\u6c42\u7684\u5fc5\u5907\u8981\u7d20\u3002\u5bf9\u4e8e\u8fdb\u519b\u6b27\u6d32\u7ecf\u6d4e\u533a\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u516c\u53f8\u6765\u8bf4\uff0c\u51c6\u786e\u7684\u7ffb\u8bd1\u662f\u83b7\u5f97CE\u6807\u5fd7\u7684\u5fc5\u8981\u6761\u4ef6\uff0c\u5c24\u5176\u662f\u5728\u65b0\u7684MDR\u5b9e\u65bd\u4e4b\u540e\u3002<\/p>\n \u7ed3\u5408\u6211\u4eec\u5148\u8fdb\u7684\u4e91\u8bed\u8a00\u6280\u672f<\/u><\/a>\u548c\u4e13\u4e1a\u7684\u6bcd\u8bed\u8bd1\u5458<\/u><\/a>\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u4e3a\u60a8\u63d0\u4f9b\u9ad8\u8d28\u91cf\u7684\u533b\u7597\u5668\u68b0\u7ffb\u8bd1\u3002<\/p>\n \u4e86\u89e3\u66f4\u591a<\/u><\/a>\u5173\u4e8e\u6211\u4eec\u533b\u7597\u5668\u68b0\u7ffb\u8bd1\u4fe1\u606f\u3002[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/02\/medical.png” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”61%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0px|0px|0px|0px|false|false” saved_tabs=”all” 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||60px” border_width_top=”1px” border_color_top=”#cccccc” border_width_bottom=”1px” border_color_bottom=”#ccc”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_3_text_align=”center”]\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>\n\u533b\u7597\u5668\u68b0\u7ffb\u8bd1<\/h2>\n
\u8d28\u91cf\u4fdd\u8bc1<\/h2>\n\n