{"id":2613,"date":"2025-11-12T13:53:53","date_gmt":"2025-11-12T13:53:53","guid":{"rendered":"https:\/\/isogeteasy.com\/?page_id=2613"},"modified":"2025-11-16T21:13:38","modified_gmt":"2025-11-16T18:13:38","slug":"iso-134852016","status":"publish","type":"page","link":"https:\/\/isogeteasy.com\/?page_id=2613","title":{"rendered":"iso-134852016"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2613\" class=\"elementor elementor-2613\">\n\t\t\t\t<div class=\"elementor-element elementor-element-79e0499 e-flex e-con-boxed e-con e-parent\" data-id=\"79e0499\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d414ce2 e-con-full e-flex e-con e-child\" data-id=\"d414ce2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8c55cd0 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"8c55cd0\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485:2016<br>\nMedical Devices QMS<\/h2>\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<div class=\"elementor-element elementor-element-ac02f08 e-con-full e-flex e-con e-child\" data-id=\"ac02f08\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-c800c61 e-con-full e-flex e-con e-child\" data-id=\"c800c61\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-4b21071 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"4b21071\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b973c27 elementor-widget elementor-widget-text-editor\" data-id=\"b973c27\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f05308b elementor-widget elementor-widget-heading\" data-id=\"f05308b\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><h2 class=\"elementor-heading-title elementor-size-default\"><b>CERTIFICATION ISO 13485<\/b><\/h2><\/div><\/div><div class=\"elementor-element elementor-element-9750ff3 elementor-widget elementor-widget-text-editor\" data-id=\"9750ff3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>\u00a0<\/p><p>The ISO 13485:2016 Specifies Requirements For A Quality Management System Where An Organization Needs To Demonstrate Its Ability To Provide Medical Devices And Related Services That Consistently Meet Customer And Applicable Regulatory Requirements. ISO 13485:2016 Can Also Be Used By Suppliers Or External Parties That Provide Product, Including Quality Management System-Related Services To Such Organisations. ISO 17664 Specifies Requirements For The Information To Be Provided By The Medical Device Manufacturer For The Processing Of A Medical Device That Requires Cleaning Followed By Disinfection And\/Or Sterilisation To Ensure That The Device Is Safe And Effective For Its Intended Use. ISO 10993 Biological Evaluation Of Medical Devices, Evaluation And Testing Within A Risk Management Process, Is The Most Widely Used Standard For Assessing The Biocompatibility Of Medical Devices And Materials, And Provides A Framework For Determining The Appropriate Biocompatibility Steps For Planning A Biological Evaluation. GMP Good Manufacturing Practice (GMP) Is A System For Ensuring That Products Are Consistently Produced And Controlled According To Quality Standards. Also CGMP From FDA USA , GMP Pharmaceuticals, Goods Distribution Practices For Medical Devices ( GDPMD) , Good Storage Practices ( GSP) ,<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4de9bc9 e-flex e-con-boxed e-con e-parent\" data-id=\"4de9bc9\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 13485:2016 Medical Devices QMS CERTIFICATION ISO 13485 \u00a0 The ISO 13485:2016 Specifies Requirements For A Quality Management System Where An Organization Needs To Demonstrate Its Ability To Provide Medical Devices And Related Services That Consistently Meet Customer And Applicable Regulatory Requirements. ISO 13485:2016 Can Also Be Used By Suppliers Or External Parties That Provide [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-2613","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/pages\/2613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/isogeteasy.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2613"}],"version-history":[{"count":16,"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/pages\/2613\/revisions"}],"predecessor-version":[{"id":2891,"href":"https:\/\/isogeteasy.com\/index.php?rest_route=\/wp\/v2\/pages\/2613\/revisions\/2891"}],"wp:attachment":[{"href":"https:\/\/isogeteasy.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}