{"id":2464,"date":"2023-02-06T23:31:54","date_gmt":"2023-02-06T23:31:54","guid":{"rendered":"http:\/\/inter-certification.com\/?page_id=2464"},"modified":"2023-05-24T16:13:46","modified_gmt":"2023-05-24T16:13:46","slug":"iso-13485","status":"publish","type":"page","link":"http:\/\/inter-certification.com\/?page_id=2464","title":{"rendered":"ISO 13485"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2464\" class=\"elementor elementor-2464\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4944623 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4944623\" 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-44d93db\" data-id=\"44d93db\" 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-ca80c46 elementor-widget elementor-widget-spacer\" data-id=\"ca80c46\" 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 - v3.10.2 - 29-01-2023 *\/\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\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4990593 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4990593\" 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-81072e8\" data-id=\"81072e8\" 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-8c6d56a elementor-widget elementor-widget-text-editor\" data-id=\"8c6d56a\" 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 - v3.10.2 - 29-01-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;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<h2><span style=\"font-weight: bolder; color: var(--insur-black);\">ISO 13485 :2016<\/span><\/h2>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78c829b elementor-widget elementor-widget-text-editor\" data-id=\"78c829b\" 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<h2><span style=\"background-color: transparent; color: #2f3e95; font-family: Arial; font-size: 13pt; font-weight: bold; white-space: pre-wrap;\">About:<\/span><\/h2>\n<p align=\"justify\"><span style=\"color: #000000;\">Stakeholders of medical device sector must meet quality and safety requirements. To guarantee the compliance of your medical devices with regulations, and to meet the expectations of your customers while enhancing your quality procedures, ISO 13485 is the ultimate solution.<\/span><\/p>\n<p align=\"justify\"><span style=\"color: #000000;\">The latest version of ISO13485 was published in 2016. It is based on the <a href=\"https:\/\/inter-certification.com\/?page_id=2029\">ISO 9001<\/a> standard with some additional requirements which are specific to medical devices, such as risk analysis, traceability, sterilization, testing and long term monitoring.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5b2cbb elementor-widget elementor-widget-image\" data-id=\"b5b2cbb\" 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 - v3.10.2 - 29-01-2023 *\/\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=\"640\" height=\"360\" src=\"http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng.png\" class=\"attachment-large size-large wp-image-2995\" alt=\"ISO 13485 ISO13485\" srcset=\"http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng.png 914w, http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng-300x169.png 300w, http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng-768x432.png 768w, http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng-570x321.png 570w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\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-751ef71 elementor-widget elementor-widget-text-editor\" data-id=\"751ef71\" 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<h2><span style=\"background-color: transparent; color: #2f3e95; font-family: Arial; font-size: 13pt; font-weight: bold; white-space: pre-wrap;\">Eligibility:<\/span><\/h2>\n<p align=\"justify\"><span style=\"color: #000000;\">ISO13485 certification mainly concerns companies that operate in the fields of design and manufacture of medical devices.The ISO 13485 certification standard can also be used in other industrial sectors, when a quality management system with additional requirements compared to an ISO 9001:2015 system, is needed.<\/span><\/p>\n\n<p align=\"justify\"><span style=\"color: #000000;\">Medical device (MD) means any instrument, device, equipment or even software intended, by its manufacturer, to be used in humans for medical purposes, in particular diagnosis, prevention, control, treatment, alleviation of disease or injury.<\/span><\/p>\n<h1><span style=\"font-size: 13pt; font-family: Arial; background-color: transparent; font-weight: bold; font-variant-numeric: normal; font-variant-east-asian: normal; vertical-align: baseline; white-space: pre-wrap; color: #2f3e95;\">Advantages ?<\/span><\/h1>\n<ul>\n \t<li><span style=\"color: #000000;\">Recognition and opportunity to meet the needs of the international market<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Meeting legal and regulatory requirements<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Recognition of the certificate nationally and internationally and especially by other industrial fields<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Improved product\u2019s safety and traceability management<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Manufacturing process controls improving quality and productivity<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Streamlining business processes and improving efficiency<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Better commercial performance and increased durability.<\/span><\/li>\n<\/ul>\n<span style=\"font-size: 13pt; font-family: Arial; background-color: transparent; font-weight: bold; font-variant-numeric: normal; font-variant-east-asian: normal; vertical-align: baseline; white-space: pre-wrap; color: #2f3e95;\">Why choose us ?<\/span>\n<ul>\n \t<li><span style=\"color: #000000;\">International recognition for ISO 13485 certification<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Organization accredited on all branches of the ISO13485 standard<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Extensive experience in the field of ISO13485 certification in Europe and Eastern countries<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Auditors from the medical and health field, experts in the specific requirements of the standard and which makes you have exactly what you need.<\/span><\/li>\n \t<li><span style=\"color: #000000;\">Very competitive costs and irreproachable responsiveness during the certification process<\/span><\/li>\n<\/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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e9029ec\" data-id=\"e9029ec\" 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-3d9ce45 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d9ce45\" 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-8a39c6f\" data-id=\"8a39c6f\" 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-bfb5285 elementor-widget elementor-widget-spacer\" data-id=\"bfb5285\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\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\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 About: Stakeholders of medical device sector must meet quality and safety requirements. To guarantee the compliance of your medical devices with regulations, and to meet the expectations of your customers while enhancing your quality procedures, ISO 13485 is the ultimate solution. The latest version of ISO13485 was published in 2016. It is [&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-2464","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 13485 - International Certification<\/title>\n<meta name=\"description\" content=\"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/inter-certification.com\/?page_id=2464\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - International Certification\" \/>\n<meta property=\"og:description\" content=\"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers\" \/>\n<meta property=\"og:url\" content=\"http:\/\/inter-certification.com\/?page_id=2464\" \/>\n<meta property=\"og:site_name\" content=\"International Certification\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=100092675166553\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-24T16:13:46+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/inter-certification.com\/?page_id=2464\",\"url\":\"http:\/\/inter-certification.com\/?page_id=2464\",\"name\":\"ISO 13485 - International Certification\",\"isPartOf\":{\"@id\":\"http:\/\/inter-certification.com\/#website\"},\"datePublished\":\"2023-02-06T23:31:54+00:00\",\"dateModified\":\"2023-05-24T16:13:46+00:00\",\"description\":\"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers\",\"breadcrumb\":{\"@id\":\"http:\/\/inter-certification.com\/?page_id=2464#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/inter-certification.com\/?page_id=2464\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/inter-certification.com\/?page_id=2464#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/inter-certification.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485\"}]},{\"@type\":\"WebSite\",\"@id\":\"http:\/\/inter-certification.com\/#website\",\"url\":\"http:\/\/inter-certification.com\/\",\"name\":\"International Certification\",\"description\":\"International Certification\",\"publisher\":{\"@id\":\"http:\/\/inter-certification.com\/#organization\"},\"alternateName\":\"Intercert Advancy\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"http:\/\/inter-certification.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"http:\/\/inter-certification.com\/#organization\",\"name\":\"International Certification\",\"alternateName\":\"Intercert Advancy\",\"url\":\"http:\/\/inter-certification.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"http:\/\/inter-certification.com\/#\/schema\/logo\/image\/\",\"url\":\"http:\/\/inter-certification.com\/wp-content\/uploads\/2022\/07\/cropped-trans_logo.png\",\"contentUrl\":\"http:\/\/inter-certification.com\/wp-content\/uploads\/2022\/07\/cropped-trans_logo.png\",\"width\":2310,\"height\":970,\"caption\":\"International Certification\"},\"image\":{\"@id\":\"http:\/\/inter-certification.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/profile.php?id=100092675166553\",\"https:\/\/www.linkedin.com\/in\/intercert-advancy-b0644a259\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ISO 13485 - International Certification","description":"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/inter-certification.com\/?page_id=2464","og_locale":"fr_FR","og_type":"article","og_title":"ISO 13485 - International Certification","og_description":"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers","og_url":"http:\/\/inter-certification.com\/?page_id=2464","og_site_name":"International Certification","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=100092675166553","article_modified_time":"2023-05-24T16:13:46+00:00","og_image":[{"url":"http:\/\/inter-certification.com\/wp-content\/uploads\/2023\/02\/sur-page-13kbpng.png"}],"twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/inter-certification.com\/?page_id=2464","url":"http:\/\/inter-certification.com\/?page_id=2464","name":"ISO 13485 - International Certification","isPartOf":{"@id":"http:\/\/inter-certification.com\/#website"},"datePublished":"2023-02-06T23:31:54+00:00","dateModified":"2023-05-24T16:13:46+00:00","description":"ISO 13485 is the ultimate solution to guarantee the compliance of your medical devices, and to meet the expectations of your customers","breadcrumb":{"@id":"http:\/\/inter-certification.com\/?page_id=2464#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["http:\/\/inter-certification.com\/?page_id=2464"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/inter-certification.com\/?page_id=2464#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/inter-certification.com\/"},{"@type":"ListItem","position":2,"name":"ISO 13485"}]},{"@type":"WebSite","@id":"http:\/\/inter-certification.com\/#website","url":"http:\/\/inter-certification.com\/","name":"International Certification","description":"International Certification","publisher":{"@id":"http:\/\/inter-certification.com\/#organization"},"alternateName":"Intercert Advancy","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"http:\/\/inter-certification.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"http:\/\/inter-certification.com\/#organization","name":"International Certification","alternateName":"Intercert Advancy","url":"http:\/\/inter-certification.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"http:\/\/inter-certification.com\/#\/schema\/logo\/image\/","url":"http:\/\/inter-certification.com\/wp-content\/uploads\/2022\/07\/cropped-trans_logo.png","contentUrl":"http:\/\/inter-certification.com\/wp-content\/uploads\/2022\/07\/cropped-trans_logo.png","width":2310,"height":970,"caption":"International Certification"},"image":{"@id":"http:\/\/inter-certification.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=100092675166553","https:\/\/www.linkedin.com\/in\/intercert-advancy-b0644a259\/"]}]}},"_links":{"self":[{"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/pages\/2464"}],"collection":[{"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/inter-certification.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2464"}],"version-history":[{"count":44,"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/pages\/2464\/revisions"}],"predecessor-version":[{"id":5295,"href":"http:\/\/inter-certification.com\/index.php?rest_route=\/wp\/v2\/pages\/2464\/revisions\/5295"}],"wp:attachment":[{"href":"http:\/\/inter-certification.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}