{"id":9933,"date":"2023-08-17T09:54:33","date_gmt":"2023-08-17T09:54:33","guid":{"rendered":"https:\/\/www.katsanas.com\/our-services\/product-design\/quality-certification\/"},"modified":"2023-11-24T12:36:33","modified_gmt":"2023-11-24T12:36:33","slug":"quality-certification","status":"publish","type":"page","link":"https:\/\/www.katsanas.com\/en\/our-services\/product-design\/quality-certification\/","title":{"rendered":"Quality Certification"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"9933\" class=\"elementor elementor-9933 elementor-7548\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-82d2771 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default qodef-elementor-content-no\" data-id=\"82d2771\" 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-f555eae\" data-id=\"f555eae\" 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-a260e1b elementor-vertical-align-middle elementor-widget elementor-widget-image-box\" data-id=\"a260e1b\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>.elementor-widget-image-box .elementor-image-box-content{width:100%}@media (min-width:768px){.elementor-widget-image-box.elementor-position-left .elementor-image-box-wrapper,.elementor-widget-image-box.elementor-position-right .elementor-image-box-wrapper{display:flex}.elementor-widget-image-box.elementor-position-right .elementor-image-box-wrapper{text-align:right;flex-direction:row-reverse}.elementor-widget-image-box.elementor-position-left .elementor-image-box-wrapper{text-align:left;flex-direction:row}.elementor-widget-image-box.elementor-position-top .elementor-image-box-img{margin:auto}.elementor-widget-image-box.elementor-vertical-align-top .elementor-image-box-wrapper{align-items:flex-start}.elementor-widget-image-box.elementor-vertical-align-middle .elementor-image-box-wrapper{align-items:center}.elementor-widget-image-box.elementor-vertical-align-bottom .elementor-image-box-wrapper{align-items:flex-end}}@media (max-width:767px){.elementor-widget-image-box .elementor-image-box-img{margin-left:auto!important;margin-right:auto!important;margin-bottom:15px}}.elementor-widget-image-box .elementor-image-box-img{display:inline-block}.elementor-widget-image-box .elementor-image-box-title a{color:inherit}.elementor-widget-image-box .elementor-image-box-wrapper{text-align:center}.elementor-widget-image-box .elementor-image-box-description{margin:0}<\/style><div class=\"elementor-image-box-wrapper\"><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">13485 Quality Management System (QMS) in Medical Devices<\/h3><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f49925a elementor-widget elementor-widget-text-editor\" data-id=\"f49925a\" 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 - v3.15.0 - 09-08-2023 *\/\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<div>\n<p>Katsan has had ISO 13485 Medical Devices &#8211; Quality Management System since 2005. ISO 13485 is an internationally recognized standard that contains specific requirements for medical devices. It is a quality management system that companies must establish within the scope of CE marking in medical devices.<br><br>As Katsan, we provide training on the requirements regarding ISO 13485:2016 Medical Devices &#8211; Quality Management System, and in the first step, we create a quality management system department within the company, and then ensure that ISO 13485 can be applied by all departments. Training is given and work is carried out with the company on why the ISO 13485 system is necessary, what its general requirements are, other international standards that need to be applied together, documentation, the efficiency of the system and the sustainability of this system.<\/p>\n<\/div>\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-a3fa4cb\" data-id=\"a3fa4cb\" 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-c584736 elementor-widget elementor-widget-image\" data-id=\"c584736\" 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 - v3.15.0 - 09-08-2023 *\/\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=\"200\" height=\"200\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kalite-belgelendirme.png\" class=\"attachment-full size-full wp-image-7320\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kalite-belgelendirme.png 200w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kalite-belgelendirme-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kalite-belgelendirme-82x82.png 82w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/>\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-94bb287 elementor-section-boxed elementor-section-height-default elementor-section-height-default qodef-elementor-content-no\" data-id=\"94bb287\" 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-14 elementor-top-column elementor-element elementor-element-825e856\" data-id=\"825e856\" 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-8184b64 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"8184b64\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-surdurulebilirlik.png\" class=\"attachment-full size-full wp-image-7593\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-surdurulebilirlik.png 300w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-surdurulebilirlik-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-surdurulebilirlik-82x82.png 82w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">Sustainability<\/h3><\/div><\/div>\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-14 elementor-top-column elementor-element elementor-element-b6a4ebf\" data-id=\"b6a4ebf\" 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-fdf8c5f elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"fdf8c5f\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-planlama.png\" class=\"attachment-full size-full wp-image-7592\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-planlama.png 300w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-planlama-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-planlama-82x82.png 82w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">Planning<\/h3><\/div><\/div>\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-14 elementor-top-column elementor-element elementor-element-2db0651\" data-id=\"2db0651\" 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-75b91ec elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"75b91ec\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kurulum.png\" class=\"attachment-full size-full wp-image-7591\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kurulum.png 300w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kurulum-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-kurulum-82x82.png 82w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">Setup<\/h3><\/div><\/div>\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-14 elementor-top-column elementor-element elementor-element-d8175e1\" data-id=\"d8175e1\" 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-d4bcd84 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"d4bcd84\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-uygulama.png\" class=\"attachment-full size-full wp-image-7590\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-uygulama.png 300w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-uygulama-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-uygulama-82x82.png 82w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">APPLICATION<\/h3><\/div><\/div>\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-14 elementor-top-column elementor-element elementor-element-127a4ff elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet\" data-id=\"127a4ff\" 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<div class=\"elementor-column elementor-col-14 elementor-top-column elementor-element elementor-element-2eb2ccc\" data-id=\"2eb2ccc\" 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-2f57f19 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"2f57f19\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-yonetim.png\" class=\"attachment-full size-full wp-image-7589\" alt=\"\" srcset=\"https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-yonetim.png 300w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-yonetim-150x150.png 150w, https:\/\/www.katsanas.com\/wp-content\/uploads\/2023\/08\/ikon-yonetim-82x82.png 82w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">Management<\/h3><\/div><\/div>\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-14 elementor-top-column elementor-element elementor-element-6cbe255 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet\" data-id=\"6cbe255\" 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-f973924 elementor-section-boxed elementor-section-height-default elementor-section-height-default qodef-elementor-content-no\" data-id=\"f973924\" 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-7c58a3f\" data-id=\"7c58a3f\" 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-743f42a elementor-widget elementor-widget-heading\" data-id=\"743f42a\" 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 - v3.15.0 - 09-08-2023 *\/\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\">Technical File Preparation<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da870b8 elementor-widget elementor-widget-text-editor\" data-id=\"da870b8\" 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>The technical file preparation process for medical device manufacturers is a detailed process that involves long-term work. To prepare the technical file, the responsible personnel must comply with the standards, Medical Device Regulation, published regulations and Turkish Republic. It is of great importance to have knowledge of the requirements of the legislation published by the Ministry of Health.<br \/>Technical file documentation is a process that should be supported by as much evidence as possible. Product general safety and performance requirements, reliability,<br \/>Issues such as compliance with standards must be presented with objective evidence.<br \/>As Katsan, training is provided with the aim of providing guidance in providing evidence.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e2e41fb elementor-widget elementor-widget-heading\" data-id=\"e2e41fb\" 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\">Preliminary Clinical Evaluation (Biocompatibility Studies)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0053dd2 elementor-widget elementor-widget-text-editor\" data-id=\"0053dd2\" 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>Pre-clinical tests are an important point that medical device regulation also emphasizes in clinical evaluation studies. These are biocompatibility studies. Biocompatibility is, by definition, a measure of how compatible a device is with a biological system. The ISO 10993 standard defines biocompatibility as \u201cthe ability of a medical device or material to perform with an appropriate host response in a particular application.\u201d<\/p>\n<p>Training and consultancy services are provided on biocompatibility and clinical evaluation of medical devices, legislation.<\/p>\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\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>13485 Quality Management System (QMS) in Medical Devices Katsan has had ISO 13485 Medical Devices &#8211; Quality Management System since 2005. ISO 13485 is an internationally recognized standard that contains specific requirements for medical devices. It is a quality management system that companies must establish within the scope of CE marking in medical devices. As [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":9931,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-9933","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/pages\/9933","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/comments?post=9933"}],"version-history":[{"count":11,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/pages\/9933\/revisions"}],"predecessor-version":[{"id":13090,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/pages\/9933\/revisions\/13090"}],"up":[{"embeddable":true,"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/pages\/9931"}],"wp:attachment":[{"href":"https:\/\/www.katsanas.com\/en\/wp-json\/wp\/v2\/media?parent=9933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}