{"id":1058,"date":"2024-01-11T13:44:39","date_gmt":"2024-01-11T05:44:39","guid":{"rendered":"https:\/\/www.kanglifehealth.com\/?page_id=1058"},"modified":"2024-04-04T12:20:50","modified_gmt":"2024-04-04T04:20:50","slug":"%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e8%be%85%e5%af%bc","status":"publish","type":"page","link":"https:\/\/www.kanglifehealth.com\/zh_cn\/%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e8%be%85%e5%af%bc\/","title":{"rendered":"\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8f85\u5bfc"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1058\" class=\"elementor elementor-1058\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e215bc7 e-flex e-con-boxed e-con e-parent\" data-id=\"e215bc7\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-106329d e-con-full e-flex e-con e-child\" data-id=\"106329d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8987177 elementor-widget elementor-widget-heading\" data-id=\"8987177\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8f85\u5bfc<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f40bbb elementor-widget elementor-widget-text-editor\" data-id=\"4f40bbb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u662f\u4fdd\u8bc1\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7684\u91cd\u8981\u624b\u6bb5\uff0c\u5176\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\u3002\u800c\u533b\u7597\u5668\u68b0\u4e3b\u6d41\u5e02\u573a\u7684\u56fd\u5bb6\u5bf9\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u5927\u540c\u5c0f\u5f02\uff0c\u4f46\u662f\u5feb\u901f\u8bc6\u522b\u4e0d\u540c\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u7684\u4e0d\u540c\u8981\u6c42\u5e76\u843d\u5b9e\u5230\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e2d\uff0c\u5bf9\u4e0d\u5c11\u4f01\u4e1a\u6765\u8bb2\uff0c\u5374\u662f\u4e00\u4e2a\u4e0d\u5c0f\u7684\u96be\u9898\u3002<\/p><p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u5eb7\u85aa\u62e5\u6709\u4e00\u652f\u4ece\u4e8b\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7ba1\u7406\u548c\u8ba4\u8bc1\u591a\u5e74\u7684\u4e13\u5bb6\u961f\u4f0d\uff0c\u53ef\u4ee5\u8f85\u5bfc\u4f01\u4e1a\u5feb\u901f\u5efa\u7acb\u4e0d\u540c\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fhsa7cs elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fhsa7cs\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-0774ce9\" data-id=\"0774ce9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7586c77 elementor-widget elementor-widget-heading\" data-id=\"7586c77\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54c3204 elementor-widget elementor-widget-text-editor\" data-id=\"54c3204\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes\uff08\u533b\u7597\u5668\u68b0 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\uff09\u662f\u7531\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7 ISO\/TC 210\u53d1\u5e03\u7684\uff0c\u76ee\u524d\u73b0\u884c\u6709\u6548\u7248\u672c\u662f2016\u5e74\u7248\u672c\u3002<\/p><p>\u00a0ISO 13485\uff1a2016 \u89c4\u5b9a\u4e86\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u8981\u6c42\uff0c\u7ec4\u7ec7\u9700\u8981\u8bc1\u660e\u5176\u63d0\u4f9b\u59cb\u7ec8\u5982\u4e00\u5730\u6ee1\u8db3\u5ba2\u6237\u548c\u9002\u7528\u6cd5\u89c4\u8981\u6c42\u7684\u533b\u7597\u5668\u68b0\u548c\u76f8\u5173\u670d\u52a1\u7684\u80fd\u529b\u3002\u8fd9\u4e9b\u7ec4\u7ec7\u53ef\u4ee5\u53c2\u4e0e\u751f\u547d\u5468\u671f\u7684\u4e00\u4e2a\u6216\u591a\u4e2a\u9636\u6bb5\uff0c\u5305\u62ec\u533b\u7597\u5668\u68b0\u7684\u8bbe\u8ba1\u548c\u5f00\u53d1\u3001\u751f\u4ea7\u3001\u50a8\u5b58\u548c\u5206\u9500\u3001\u5b89\u88c5\u6216\u7ef4\u4fee\uff0c\u4ee5\u53ca\u8bbe\u8ba1\u548c\u5f00\u53d1\u6216\u63d0\u4f9b\u76f8\u5173\u6d3b\u52a8\uff08\u4f8b\u5982\u6280\u672f\u652f\u6301\uff09\u3002ISO 13485\uff1a2016 \u4e5f\u53ef\u7528\u4e8e\u5411\u6b64\u7c7b\u7ec4\u7ec7\u63d0\u4f9b\u4ea7\u54c1\uff08\u5305\u62ec\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u76f8\u5173\u670d\u52a1\uff09\u7684\u4f9b\u5e94\u5546\u6216\u5916\u90e8\u5404\u65b9\u3002<\/p><p>ISO 13485\uff1a2016\u662f\u76ee\u524d\u8ba4\u53ef\u5ea6\u6700\u4e3a\u5e7f\u6cdb\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-538feee\" data-id=\"538feee\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dfb37fb elementor-widget elementor-widget-image\" data-id=\"dfb37fb\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"830\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1.png\" class=\"attachment-full size-full wp-image-1471\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1.png 768w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1-278x300.png 278w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e642242 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e642242\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5a14d99\" data-id=\"5a14d99\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d30a2c3 elementor-widget elementor-widget-image\" data-id=\"d30a2c3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/02\/FDA-150x150.png\" class=\"attachment-thumbnail size-thumbnail wp-image-1613\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-0484998\" data-id=\"0484998\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-06f761c elementor-widget elementor-widget-heading\" data-id=\"06f761c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">QMSR (\u539fQSR 820)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90b0ed2 elementor-widget elementor-widget-text-editor\" data-id=\"90b0ed2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u5c40\uff08FDA\uff09\u6839\u636e\u5173\u4e8e\u533b\u7597\u5668\u68b0\u7ba1\u7406\u7684\u6700\u9ad8\u6cd5\u5f8b\u6027\u6587\u4ef6\u300a\u8054\u90a6\u98df\u54c1,\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848(Federal Food, Drug, and Cosmetic Act)\u300b\u800c\u5236\u5b9a\u7684\u89c4\u8303\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u8d28\u91cf\u4f53\u7cfb\u8981\u6c42\u7684\u6cd5\u89c4,\u5373Quality Management System Regulation\uff0c\u7b80\u79f0QMSR\u3002<\/p>\n<p>QMSR\u63cf\u8ff0\u4e86\u73b0\u884c\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u7684\u8981\u6c42(CGMP). \u89c4\u5b9a\u4e86\u6240\u6709\u533b\u7597\u5668\u68b0\u5728\u8bbe\u8ba1\uff0c\u5236\u9020\uff0c\u5305\u88c5\uff0c\u6807\u7b7e\uff0c\u8d2e\u5b58\uff0c\u5b89\u88c5\u548c\u670d\u52a1\u4e2d\u4f7f\u7528\u7684\u65b9\u6cd5\uff0c\u8bbe\u65bd\u548c\u63a7\u5236\u3002\u8fd9\u4e9b\u8981\u6c42\u662f\u4e3a\u4e86\u786e\u4fdd\u533b\u7597\u5668\u68b0\u6210\u54c1\u7684\u5b89\u5168\u548c\u6709\u6548\uff0c\u5e76\u9075\u4ece\u7f8e\u56fd\u98df\u54c1\uff0c\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u3002<\/p>\n<p>QMSR\u63d0\u51fa\u4e86\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u57fa\u672c\u8981\u6c42\u3002\u6240\u6709\u5f80\u7f8e\u56fd\u9500\u552e\u533b\u7597\u5668\u68b0\u7684\u4f01\u4e1a\u90fd\u6709\u8d23\u4efb\u7406\u89e3\u3001\u6267\u884c\u5e76\u7b26\u5408\u8fd9\u90e8\u5206\u6cd5\u89c4\u7684\u8981\u6c42\uff0c\u662f\u591a\u6570\u533b\u7597\u5668\u68b0\u5728\u7f8e\u56fd\u4e0a\u5e02\u4e4b\u524d\u5fc5\u987b\u9075\u5b88\u3001\u4e0a\u5e02\u4e4b\u540e\u968f\u65f6\u53ef\u80fd\u62bd\u67e5\u7684\u57fa\u672c\u8981\u6c42\u3002\u8fd9\u79cd\u62bd\u67e5\u5373\u901a\u5e38\u6240\u8bf4\u7684FDA \u5de5\u5382\u68c0\u67e5\u6216\u98de\u884c\u68c0\u67e5\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fb44667 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fb44667\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c8f7984\" data-id=\"c8f7984\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed3c03b elementor-widget elementor-widget-heading\" data-id=\"ed3c03b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">GMP<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44b8fec elementor-widget elementor-widget-text-editor\" data-id=\"44b8fec\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u4e2d\u56fdGMP\uff0c\u5373\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082014\u5e74\u7b2c64\u53f7\uff09\u662f\u4e3a\u52a0\u5f3a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u76d1\u7763\u7ba1\u7406\uff0c\u89c4\u8303\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\uff0c\u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff08\u56fd\u52a1\u9662\u4ee4\u7b2c650\u53f7\uff09\u3001\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u76d1\u7763\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u4ee4\u7b2c7\u53f7\uff09\u800c\u5236\u5b9a\u7684\u3002\u4e2d\u56fdGMP\u662f\u6cd5\u89c4\u89c4\u5b9a\uff0c\u8981\u6c42\u5f3a\u5236\u6267\u884c\u3002\u4e5f\u5c31\u662f\u5728\u4e2d\u56fd\u751f\u4ea7\u9500\u552e\u7684\u533b\u7597\u5668\u68b0\u5fc5\u987b\u7b26\u5408GMP\u8981\u6c42\u3002<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c1ad8ed\" data-id=\"c1ad8ed\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-782379f elementor-widget elementor-widget-image\" data-id=\"782379f\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp.png\" class=\"attachment-full size-full wp-image-1480\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp.png 800w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-300x300.png 300w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-150x150.png 150w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-768x768.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3943bf5 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3943bf5\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-301d0e5\" data-id=\"301d0e5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fa2cb5e elementor-widget elementor-widget-image\" data-id=\"fa2cb5e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"248\" height=\"175\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/\u4e0b\u8f7d-e1707052618743.png\" class=\"attachment-full size-full wp-image-1473\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-809b7c9\" data-id=\"809b7c9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-999ffbc elementor-widget elementor-widget-heading\" data-id=\"999ffbc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDSAP<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5de4e48 elementor-widget elementor-widget-text-editor\" data-id=\"5de4e48\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u533b\u7597\u5668\u68b0\u5355\u4e00\u5ba1\u6838\u65b9\u6848\uff08Medical Device Single Audit Program \uff0c\u7f29\u5199\u4e3aMDSAP\uff09\u662f\u7531\u56fd\u9645\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u8005\u8bba\u575b\uff08IMDRF\uff09\u53d1\u8d77\uff0c\u4ee5ISO 13485\u4e3a\u57fa\u7840\uff0c\u7ed3\u5408\u4e94\u4e2a\u53c2\u4e0e\u56fd\uff08\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u3001\u5df4\u897f\u3001\u6fb3\u5927\u5229\u4e9a\u548c\u65e5\u672c\uff09\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u7531\u8ba4\u53ef\u7684\u5ba1\u6838\u673a\u6784\u8fdb\u884c\u4e00\u6b21\u5ba1\u6838\u6ee1\u8db3\u591a\u56fd\u6cd5\u89c4\u8981\u6c42\u7684\u65b9\u6848\u3002\u533b\u7597\u5668\u68b0\u5355\u4e00\u5ba1\u6838\u7a0b\u5e8f (MDSAP) \u63d0\u4f9b\u5355\u4e00\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u5ba1\u6838\uff0c\u4ee5\u6ee1\u8db3\u6240\u6709\u53c2\u4e0e\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\u3002<\/p><p><strong>MDSAP\u8ba4\u8bc1\u7684\u4f18\u52bf<\/strong><\/p><p>\u7b80\u5355\u8bf4\u5c31\u662f\uff1a \u4e00\u6b21\u62ff\u8bc1\uff0c\u4e94\u56fd\u901a\u884c\uff08\u5965\u3001\u5df4\u3001\u52a0\u3001\u65e5\u3001\u7f8e\uff09<\/p><ul><li>\u51cf\u8f7b\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u591a\u91cd\u6cd5\u89c4\u5ba1\u6838\u7684\u8d1f\u62c5\u548c\u5e72\u6270<\/li><li>\u63d0\u4f9b\u53ef\u9884\u6d4b\u7684\u5ba1\u6838\u8ba1\u5212\uff08\u5305\u62ec\u5ba1\u6838\u5f00\u59cb\u548c\u7ed3\u675f\u65e5\u7a0b\uff09<\/li><li>\u51ed\u5355\u4e00\u5ba1\u6838\u8fdb\u5165\u591a\u4e2a\u5e02\u573a\uff0c\u4ece\u800c\u6539\u5584\u60a3\u8005\u5065\u5eb7\u72b6\u51b5\u548c\u83b7\u5f97\u6cbb\u7597\u7684\u673a\u4f1a\uff0c\u4f7f\u5e7f\u5927\u60a3\u8005\u53d7\u76ca<\/li><li>\u5229\u7528\u76d1\u7ba1\u8d44\u6e90\uff0c\u8282\u7701\u65f6\u95f4\u548c\u6210\u672c<\/li><li>\u53ef\u5c06ISO 13485\uff08\u533b\u7597\u5668\u68b0QMS\uff09\u8bc4\u5ba1\u5305\u542b\u5728\u5185<\/li><li>\u5ba1\u6838\u8981\u6c42\u5305\u62ec\u6fb3\u5927\u5229\u4e9a\u3001\u5df4\u897f\u3001\u52a0\u62ff\u5927\u3001\u65e5\u672c\u548c\u7f8e\u56fd\u7684\u6cd5\u89c4\u8981\u6c42<\/li><li>\u51cf\u5c11\u5904\u7406\u591a\u91cd\u5ba1\u6838\u53d1\u73b0\u6240\u8017\u7528\u7684\u65f6\u95f4\u548c\u8d44\u6e90<\/li><li>\u63d0\u5347\u884c\u4e1a\u7684\u900f\u660e\u5ea6<\/li><li>\u5f53\u524d\uff0c\u533b\u7597\u5668\u68b0\u8fdb\u5165\u6b27\u76df\u6cd5\u89c4\u5e02\u573a\u6bd4\u8fc7\u5f80\u9700\u8981\u66f4\u9ad8\u6210\u672c\uff0cMDSAP\u63d0\u4f9b\u4e86\u6d77\u5916\u5e02\u573a\u65b0\u7684\u53ef\u80fd\uff0c\u5e76\u4fdd\u6301\u5728\u4e00\u4e2a\u53ef\u63a5\u53d7\u7684\u6210\u672c\u6c34\u5e73<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-daa2035 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"daa2035\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e767510\" data-id=\"e767510\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f69a079 elementor-widget elementor-widget-heading\" data-id=\"f69a079\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IVDR\/MDR \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5347\u7ea7<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc23835 elementor-widget elementor-widget-text-editor\" data-id=\"bc23835\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>\u5173\u4e8e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u6b27\u76df<span lang=\"EN-US\">MDR\/IVDR<\/span>\u6cd5\u89c4\u7b2c<span lang=\"EN-US\">10<\/span>\u6761\u7b2c<span lang=\"EN-US\">8<\/span>\u70b9\u660e\u786e\u8981\u6c42\uff1a\u5236\u9020\u5546\u5e94\u786e\u4fdd\u91c7\u53d6\u5fc5\u8981\u6d41\u7a0b\uff0c\u4f7f\u4ea7\u54c1\u7cfb\u5217\u7684\u751f\u4ea7\u7b26\u5408\u672c\u6cd5\u89c4\u7684\u8981\u6c42\u3002<\/p><p>\u7b26\u5408<span lang=\"EN-US\">MDR\\IVDR<\/span>\u6cd5\u89c4\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e94\u81f3\u5c11\u5305\u62ec\u4ee5\u4e0b\u65b9\u9762\uff1a<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">1<\/span>\u3001\u6cd5\u89c4\u7b26\u5408\u6027\u6218\u7565\uff0c\u5305\u62ec\u7b26\u5408\u6027\u8bc4\u4f30\u6d41\u7a0b\u7684\u9075\u5b88\u548c\u7cfb\u7edf\u6240\u6db5\u76d6\u7684\u5668\u68b0\u7684\u53d8\u66f4\u7ba1\u7406<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">2<\/span>\u3001\u786e\u5b9a\u9002\u7528\u7684\u901a\u7528\u5b89\u5168\u4e0e\u6027\u80fd\u8981\u6c42\uff0c\u5bfb\u627e\u6ee1\u8db3\u8fd9\u4e9b\u8981\u6c42\u7684\u9009\u9879<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">3<\/span>\u3001\u7ba1\u7406\u804c\u8d23<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">4<\/span>\u3001\u8d44\u6e90\u7ba1\u7406\uff0c\u5305\u62ec\u9009\u62e9\u548c\u7ba1\u7406\u4f9b\u5e94\u5546\u548c\u5206\u5305\u5546<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">5<\/span>\u3001\u98ce\u9669\u7ba1\u7406<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">6<\/span>\u3001\u4e34\u5e8a\u8bc4\u4ef7<span lang=\"EN-US\">\/<\/span>\u6027\u80fd\u8bc4\u4f30\uff0c\u5305\u62ec\u4e0a\u5e02\u540e<span lang=\"EN-US\">PMCF\/PMPF<\/span><\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">7<\/span>\u3001\u4ea7\u54c1\u5b9e\u73b0\uff0c\u5305\u62ec\u7b56\u5212\u3001\u8bbe\u8ba1\u3001\u7814\u53d1\u3001\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">8<\/span>\u3001\u9a8c\u8bc1\u6240\u6709\u76f8\u5173\u5668\u68b0\u7684<span lang=\"EN-US\">UDI<\/span>\u5206\u914d\uff0c\u5e76\u786e\u4fdd\u63d0\u4f9b\u7684\u4fe1\u606f\u4e00\u81f4\u6027\u548c\u6709\u6548\u6027<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">9<\/span>\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u7cfb\u7edf\uff0c\u5efa\u7acb\u3001\u5b9e\u65bd\u548c\u7ef4\u62a4\u4e0a\u5e02\u540e\u76d1\u7ba1\u4f53\u7cfb<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">10<\/span>\u3001\u4e0e\u4e3b\u7ba1\u673a\u6784\u3001\u516c\u544a\u673a\u6784\u3001\u5176\u4ed6\u7ecf\u6d4e\u8fd0\u8425\u5546\u3001\u5ba2\u6237\u548c<span lang=\"EN-US\">\/<\/span>\u6216\u5176\u4ed6\u5229\u76ca\u76f8\u5173\u4eba\u6c9f\u901a<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">11<\/span>\u3001\u4e8b\u6545\u62a5\u544a<span lang=\"EN-US\">&amp;FSCA<\/span>\uff1a\u8b66\u6212\u60c5\u51b5\u4e0b\u7684\u4e25\u91cd\u4e8b\u4ef6\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\u7684\u62a5\u544a\u6d41\u7a0b<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">12<\/span>\u3001<span lang=\"EN-US\">CAPA<\/span>\u7ba1\u7406\uff1a\u7ea0\u6b63\u63aa\u65bd\u548c\u9884\u9632\u63aa\u65bd\u7684\u7ba1\u7406\u53ca\u5176\u6709\u6548\u6027\u7684\u9a8c\u8bc1<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">13<\/span>\u3001\u76d1\u89c6\u548c\u6d4b\u91cf\uff1a\u4ea7\u54c1\u3001\u6570\u636e\u5206\u6790\u548c\u4ea7\u54c1\u6539\u8fdb\u7684\u76d1\u7763\u548c\u8bc4\u4f30\u6d41\u7a0b<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-76f1287\" data-id=\"76f1287\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fbcfea6 elementor-widget elementor-widget-image\" data-id=\"fbcfea6\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"868\" height=\"540\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR.png\" class=\"attachment-full size-full wp-image-1468\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR.png 868w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR-300x187.png 300w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR-768x478.png 768w\" sizes=\"(max-width: 868px) 100vw, 868px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8f85\u5bfc \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u662f\u4fdd\u8bc1\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7684\u91cd\u8981\u624b\u6bb5\uff0c\u5176\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\u3002\u800c\u533b 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