{"id":2698,"date":"2023-09-20T11:54:53","date_gmt":"2023-09-20T10:54:53","guid":{"rendered":"https:\/\/cinabiso.co.in\/?page_id=2698"},"modified":"2023-10-09T18:45:48","modified_gmt":"2023-10-09T17:45:48","slug":"iso-13485-2","status":"publish","type":"page","link":"https:\/\/cinabiso.co.in\/?page_id=2698","title":{"rendered":"ISO 13485"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2698\" class=\"elementor elementor-2698\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ef95f03 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no\" data-id=\"ef95f03\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;tilt&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0,6V0h1000v100L0,6z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c8dd92e\" data-id=\"c8dd92e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3de19c3 elementor-widget elementor-widget-heading\" data-id=\"3de19c3\" 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 - v3.16.0 - 14-09-2023 *\/\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\">\n Medical Device Quality Management System<\/h2>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9572656 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no\" data-id=\"9572656\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ecd14f9\" data-id=\"ecd14f9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa91b36 elementor-widget elementor-widget-heading\" data-id=\"aa91b36\" 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\"><main role=\"main\" id=\"content\" class=\"acer\" aria-label=\"Content\" tabindex=\"-1\"><div itemscope=\"\" itemtype=\"https:\/\/schema.org\/Product\"><section class=\"section-navigation\"><div class=\"container\"><div class=\"row\"><div class=\"col-md-12\"><nav role=\"navigation\" aria-label=\"Children Navigation\" class=\"heading-condensed nav-relatives\"><h1><\/h1><h1>ISO 13485:2016<\/h1><\/nav><\/div><\/div><\/div><\/section><\/div><\/main>(MDQMS)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec0e276 elementor-widget elementor-widget-text-editor\" data-id=\"ec0e276\" 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 - v3.16.0 - 14-09-2023 *\/\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\n\nEN ISO 13485 is the medical device industry&#8217;s quality management system (QMS) harmonized standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.\n\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-96a3337 elementor-hidden-tablet elementor-hidden-mobile\" data-id=\"96a3337\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d92e111 elementor-widget elementor-widget-image\" data-id=\"d92e111\" 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 - v3.16.0 - 14-09-2023 *\/\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\t\t<img loading=\"lazy\" decoding=\"async\" width=\"225\" height=\"225\" src=\"https:\/\/cinabiso.co.in\/wp-content\/uploads\/2023\/10\/13485.png\" class=\"attachment-large size-large wp-image-2840\" alt=\"\" srcset=\"https:\/\/cinabiso.co.in\/wp-content\/uploads\/2023\/10\/13485.png 225w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2023\/10\/13485-150x150.png 150w, https:\/\/cinabiso.co.in\/wp-content\/uploads\/2023\/10\/13485-170x170.png 170w\" sizes=\"(max-width: 225px) 100vw, 225px\" \/>\t\t\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2d6b4cc elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no\" data-id=\"2d6b4cc\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-cd52b00\" data-id=\"cd52b00\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c67693c elementor-widget elementor-widget-text-editor\" data-id=\"c67693c\" 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>Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in.<\/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-e96bcfc\" data-id=\"e96bcfc\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c64d97f elementor-widget elementor-widget-text-editor\" data-id=\"c64d97f\" 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 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of \u2018Plan, Do, Check, Act\u2019, it is designed for regulatory compliance. Therefore, ISO 13485 includes particular requirements for organisations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. This makes it more prescriptive in nature and requires a more thoroughly documented QMS.<\/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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Quality Management System ISO 13485:2016 (MDQMS) EN ISO 13485 is the medical device industry&#8217;s quality management system (QMS) harmonized standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/2698"}],"collection":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2698"}],"version-history":[{"count":25,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/2698\/revisions"}],"predecessor-version":[{"id":3005,"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=\/wp\/v2\/pages\/2698\/revisions\/3005"}],"wp:attachment":[{"href":"https:\/\/cinabiso.co.in\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2698"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}