{"id":1052,"date":"2020-02-12T09:58:07","date_gmt":"2020-02-12T08:58:07","guid":{"rendered":"https:\/\/www.entecerma.it\/activities\/certifications\/quality-management-systems\/iso-13485\/"},"modified":"2025-07-22T17:25:57","modified_gmt":"2025-07-22T15:25:57","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/www.entecerma.it\/en\/activities\/certifications\/quality-management-systems\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"\n<p class=\"has-text-align-center has-text-color has-background\" style=\"color:#ffffff;background-color:#364f8f;font-size:18px\"><strong>ISO 13485 certification to ensure safe and quality medical devices for the global market<\/strong><\/p>\n\n<p><span class=\"s1\">ISO 13485 is the international standard for the certification of a <strong>Quality Management System<\/strong> for the <strong>medical device<\/strong> industry. Defined on the basic principles of ISO 9001 and specific industry requirements, this standard is an effective tool for manufacturing companies to implement a quality management system that takes into account the entire process of design, development, manufacturing, installation and supply of medical devices.<\/span><\/p>\n\n<p><span class=\"s1\">ISO 13485 is the most popular standard for medical device quality management and is considered the &#8220;passport&#8221; to many <strong>international markets<\/strong>, making it a key factor in the success of any company looking to expand into global markets..<\/span><\/p>\n\n<p><span class=\"s1\">In fact, ISO 13485 certification is not only advantageous as it increases the efficiency and quality of business processes, but in some cases it is mandatory to export. This is the case in Canada, which requires mandatory ISO 13485:2016 certification for medical devices in order to be placed on the Canadian market.<\/span><\/p>\n\n<p><span class=\"s1\">In Europe, ISO 13485 has been harmonized with the three EU medical device directives (MDD, AIMDD and IVDD), so certification to the <span style=\"color: #364f8f;\"><b>EN ISO 13485:2016<\/b><\/span> standard by an accredited body such as ECM automatically demonstrates compliance with specific requirements of these directives.<\/span><\/p>\n\n<div style=\"height:27px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-very-light-gray-background-color has-text-color has-background\" style=\"color:#364f8f;font-size:18px\"><strong>Why certify your company according to ISO 13485:2016?<\/strong><\/h2>\n\n<ul class=\"wp-block-list\">\n<li><span class=\"s1\">To <span style=\"color: #364f8f;\"><b>demonstrate its reliability<\/b><\/span> in producing and placing on the market medical devices that comply with the applicable regulatory requirements through the adoption of an organizational model in line with the current regulatory framework;<\/span><\/li>\n\n\n\n<li><span class=\"s1\">To <span style=\"color: #364f8f;\"><b>expand its business<\/b><\/span> to international markets where the implementation of an internationally recognized quality management system is required;<\/span><\/li>\n\n\n\n<li><span class=\"s1\">To <span style=\"color: #364f8f;\"><b>optimize business processes<\/b><\/span>, improving efficiency and limiting waste;<\/span><\/li>\n\n\n\n<li><span class=\"s1\">To <span style=\"color: #364f8f;\"><b>monitor performances<\/b><\/span> according to defined parameters that allow for continuous performance improvement while reducing risk.<\/span><\/li>\n<\/ul>\n\n<div style=\"height:21px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"has-background\" style=\"background-color:#e7e7e7\"><span class=\"s1\"><span style=\"color: #364f8f;\"><b>Ente Certificazione Macchine<\/b><\/span> is an accredited body authorized to issue the certification of Quality Management Systems in accordance with EN ISO 13485:2016, to provide manufacturers, suppliers and distributors of medical devices with a professional and competent conformity assessment service. ECM will carry out all the necessary verifications and onsite audit to arrive, once non-conformities are not detected, at the issue of the certificate according to ISO 13485 standard. Our staff will also carry out the surveillance visits scheduled during the validity period of the certificate, in order to verify the existence of the requirements over time.<\/span><\/p>\n\n<div style=\"height:38px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-499968f5 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background wp-element-button\" href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/09\/SG11_M13_Domanda_Certificazione_SGQ-Certification_applicationQMS_rev.04.docx\" style=\"background-color:#364f8f\" target=\"_blank\" rel=\"noreferrer noopener\">QMS Certification Application<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-background wp-element-button\" href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2025\/07\/SG_14-Regulation_Certification_Mng_Systems-rev.14.pdf\" style=\"background-color:#364f8f\">QMS Certification Regulation<\/a><\/div>\n<\/div>\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-cover is-light\" style=\"min-height:130px;aspect-ratio:unset;\"><img loading=\"lazy\" decoding=\"async\" width=\"2121\" height=\"1414\" class=\"wp-block-cover__image-background wp-image-2497\" alt=\"\" src=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1.jpg\" style=\"object-position:45% 52%\" data-object-fit=\"cover\" data-object-position=\"45% 52%\" srcset=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1.jpg 2121w, https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1-600x400.jpg 600w, https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1-1024x683.jpg 1024w, https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1-768x512.jpg 768w, https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1-1536x1024.jpg 1536w, https:\/\/www.entecerma.it\/wp-content\/uploads\/2020\/10\/Immagine-1-2048x1365.jpg 2048w\" sizes=\"auto, (max-width: 2121px) 100vw, 2121px\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-black-background-color has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-flow wp-block-cover-is-layout-flow\">\n<p class=\"has-text-align-center has-white-color has-text-color\" style=\"font-size:22px\"><a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"has-inline-color has-white-color\">Find out also our conformity assessment service for EU certification of your medical device<\/span><\/a><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ISO 13485 certification to ensure safe and quality medical devices for the global market ISO&#8230;<\/p>\n","protected":false},"author":1,"featured_media":2498,"parent":566,"menu_order":34,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1052","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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