{"id":3360,"date":"2023-05-29T14:44:56","date_gmt":"2023-05-29T14:44:56","guid":{"rendered":"https:\/\/icaa.com.eg\/en\/?page_id=3360"},"modified":"2023-10-25T15:09:18","modified_gmt":"2023-10-25T15:09:18","slug":"iso-134852016-medical-devices-quality-management-systems","status":"publish","type":"page","link":"https:\/\/icaa.com.eg\/en\/iso-134852016-medical-devices-quality-management-systems\/","title":{"rendered":"ISO 13485:2016 Medical Devices &#8211; Quality Management Systems"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3360\" class=\"elementor elementor-3360\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9c16e79 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9c16e79\" 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-100 elementor-top-column elementor-element elementor-element-a35340b\" data-id=\"a35340b\" 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-cbbb93e elementor-widget elementor-widget-heading\" data-id=\"cbbb93e\" 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 - v3.13.2 - 11-05-2023 *\/\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\">ISO 13485:2016 Medical Devices - Quality Management Systems<\/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-7158ec4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7158ec4\" 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-100 elementor-top-column elementor-element elementor-element-000536a\" data-id=\"000536a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\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-0e709c8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0e709c8\" 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-2631335\" data-id=\"2631335\" 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-938d637 elementor-widget elementor-widget-image\" data-id=\"938d637\" 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 - v3.13.2 - 11-05-2023 *\/\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=\"500\" height=\"333\" src=\"https:\/\/icaa.com.eg\/en\/wp-content\/uploads\/2023\/06\/ISO-134852016-Medical-Devices-Quality-Management-Systems.jpg\" class=\"attachment-full size-full wp-image-4001\" alt=\"\" srcset=\"https:\/\/icaa.com.eg\/en\/wp-content\/uploads\/2023\/06\/ISO-134852016-Medical-Devices-Quality-Management-Systems.jpg 500w, https:\/\/icaa.com.eg\/en\/wp-content\/uploads\/2023\/06\/ISO-134852016-Medical-Devices-Quality-Management-Systems-300x200.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/>\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<div class=\"elementor-element elementor-element-89c5567 elementor-widget elementor-widget-text-editor\" data-id=\"89c5567\" 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 - v3.13.2 - 11-05-2023 *\/\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<p><span style=\"text-decoration: underline;\"><strong>Introduction:<\/strong><\/span><\/p><p>ISO 13485:2016 is an international standard that specifies requirements for a quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices. As an accredited certification body by EGAC, iCAA can help organizations achieve certification to ISO 13485:2016.<\/p><p><span style=\"text-decoration: underline;\"><strong>Benefits:<\/strong><\/span><\/p><p>The benefits of ISO 13485:2016 certification include improved product quality, increased customer satisfaction, enhanced regulatory compliance, and reduced costs and risks.<\/p><p><span style=\"text-decoration: underline;\"><strong>Certification Process:<\/strong><\/span><\/p><p>The certification process involves several steps, including an application, a documentation review, an on-site audit, and issuance of the certificate. The audit process includes a review of the organization&#8217;s quality management system, as well as an assessment of its compliance with regulatory requirements.<\/p><p>Maintaining certification requires ongoing compliance with the standard and periodic surveillance audits to ensure continued compliance.<\/p><p>Key requirements of ISO 13485:2016 include a focus on risk management, product realization, process validation, and control of nonconforming products. The standard also emphasizes the importance of customer feedback, product traceability, and continuous improvement.<\/p><p><strong>iCAA. Accredited Scopes from EGAC<\/strong><\/p><ul><li><strong>MD QMS &#8211; ISO 13485 (in accordance with IAF MD 9:2023 Issue 4, Version 2)<\/strong><ul><li>Non-active Medical Devices<ul><li>General non-active, non-implantable medical devices<\/li><li>Non-active implants<\/li><li>Devices for wound care<\/li><li>Non-active dental devices and accessories<\/li><li>Non-active medical devices other than specified above.<\/li><\/ul><\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-492cd4a elementor-align-center elementor-widget elementor-widget-button\" data-id=\"492cd4a\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"https:\/\/icaa.com.eg\/en\/certification-request\/\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Apply Now<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c34e260 elementor-widget elementor-widget-spacer\" data-id=\"c34e260\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.13.2 - 11-05-2023 *\/\n.elementor-column .elementor-spacer-inner{height:var(--spacer-size)}.e-con{--container-widget-width:100%}.e-con-inner>.elementor-widget-spacer,.e-con>.elementor-widget-spacer{width:var(--container-widget-width,var(--spacer-size));--align-self:var(--container-widget-align-self,initial);--flex-shrink:0}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container,.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer,.e-con>.elementor-widget-spacer>.elementor-widget-container,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer{height:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner{height:var(--container-widget-height,var(--spacer-size))}<\/style>\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-33d0f37\" data-id=\"33d0f37\" 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-fce1cfc elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-heading\" data-id=\"fce1cfc\" 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\">Certifications<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4532a7 elementor-view-certificate-menu elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-ova_menu\" data-id=\"a4532a7\" data-element_type=\"widget\" data-widget_type=\"ova_menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"ova_menu_clasic\">\n\t\t\t<div class=\"ova_wrap_nav column NavBtn_left NavBtn_left\">\n\n\t\t\t\t<button class=\"ova_openNav\" type=\"button\">\n\t\t\t\t\t<span class=\"bar\">\n\t\t\t\t\t\t<span class=\"bar-menu-line\"><\/span>\n\t\t\t\t\t\t<span class=\"bar-menu-line\"><\/span>\n\t\t\t\t\t\t<span class=\"bar-menu-line\"><\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/button>\n\n\t\t\t\t<div class=\"ova_nav canvas_left canvas_bg_gray\">\n\t\t\t\t\t<a href=\"javascript:void(0)\" class=\"ova_closeNav\"><i class=\"fas fa-times\"><\/i><\/a>\n\t\t\t\t\t<ul id=\"menu-certificate-menu\" class=\"menu sub_menu_dir_left\"><li id=\"menu-item-3770\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3770\"><a title=\"ISO 13485:2016\" href=\"https:\/\/icaa.com.eg\/en\/iso-134852016-medical-devices-quality-management-systems\/\">ISO 13485:2016<\/a><\/li>\n<li id=\"menu-item-3771\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3771\"><a title=\"ISO 14001:2015\" href=\"https:\/\/icaa.com.eg\/en\/iso-140012015-environmental-management-systems\/\">ISO 14001:2015<\/a><\/li>\n<li id=\"menu-item-3772\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3772\"><a title=\"ISO 21001:2018\" href=\"https:\/\/icaa.com.eg\/en\/iso-210012018-educational-organizations-management-systems-for-educational-organizations\/\">ISO 21001:2018<\/a><\/li>\n<li id=\"menu-item-3773\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3773\"><a title=\"ISO 22000:2018\" href=\"https:\/\/icaa.com.eg\/en\/iso-220002018-food-safety-management-systems\/\">ISO 22000:2018<\/a><\/li>\n<li id=\"menu-item-3774\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3774\"><a title=\"ISO 22301:2019\" href=\"https:\/\/icaa.com.eg\/en\/iso-223012019-business-continuity-management-systems\/\">ISO 22301:2019<\/a><\/li>\n<li id=\"menu-item-3775\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3775\"><a title=\"ISO 22716:2007\" href=\"https:\/\/icaa.com.eg\/en\/iso-227162007-cosmetics-good-manufacturing-practices\/\">ISO 22716:2007<\/a><\/li>\n<li id=\"menu-item-3776\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3776\"><a title=\"ISO 27001:2022\" href=\"https:\/\/icaa.com.eg\/en\/iso-270012022-information-security-management-systems\/\">ISO 27001:2022<\/a><\/li>\n<li id=\"menu-item-3777\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3777\"><a title=\"ISO 45001:2018\" href=\"https:\/\/icaa.com.eg\/en\/iso-450012018-occupational-health-and-safety-management-systems\/\">ISO 45001:2018<\/a><\/li>\n<li id=\"menu-item-3778\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3778\"><a title=\"ISO 9001:2015\" href=\"https:\/\/icaa.com.eg\/en\/iso-90012015-quality-management-systems\/\">ISO 9001:2015<\/a><\/li>\n<li id=\"menu-item-3779\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-3779\"><a title=\"ISO\/IEC 20000-1:2018\" href=\"https:\/\/icaa.com.eg\/en\/iso-iec-20000-12018-it-service-management-systems\/\">ISO\/IEC 20000-1:2018<\/a><\/li>\n<\/ul>\t\t\t\t<\/div>\n\n\t\t\t\t<div class=\"ova_closeCanvas ova_closeNav\"><\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\n\t\t\n\n\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-dfd0eae elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"dfd0eae\" 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-100 elementor-top-column elementor-element elementor-element-d100532\" data-id=\"d100532\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\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>ISO 13485:2016 Medical Devices &#8211; Quality Management Systems Introduction: ISO 13485:2016 is an international standard that specifies requirements for a quality management system for organizations involved in the design, development, production, installation, and servicing of medical devices. As an accredited certification body by EGAC, iCAA can help organizations achieve certification to ISO 13485:2016. Benefits: The [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_mi_skip_tracking":false,"footnotes":""},"class_list":["post-3360","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/pages\/3360","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/comments?post=3360"}],"version-history":[{"count":31,"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/pages\/3360\/revisions"}],"predecessor-version":[{"id":4300,"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/pages\/3360\/revisions\/4300"}],"wp:attachment":[{"href":"https:\/\/icaa.com.eg\/en\/wp-json\/wp\/v2\/media?parent=3360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}