{"id":5404,"date":"2021-04-26T11:08:25","date_gmt":"2021-04-26T09:08:25","guid":{"rendered":"https:\/\/mec-abc.de\/business-services\/qualitatsmanagement\/"},"modified":"2021-11-12T08:17:32","modified_gmt":"2021-11-12T07:17:32","slug":"quality-management","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/business-services\/quality-management\/","title":{"rendered":"Quality management"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5404\" class=\"elementor elementor-5404 elementor-4580\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8c03219 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"8c03219\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\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-13eb177\" data-id=\"13eb177\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d0f4fc8 elementor-widget elementor-widget-heading\" data-id=\"d0f4fc8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Quality management<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7fd245c elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7fd245c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-710e3af elementor-widget elementor-widget-heading\" data-id=\"710e3af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-medium\">REGULATORY AFFAIRS under MDR<\/p>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\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-6768368 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"6768368\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\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-d10f65f\" data-id=\"d10f65f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-a58d898 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a58d898\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\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-inner-column elementor-element elementor-element-d028a65\" data-id=\"d028a65\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6854728 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"6854728\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a7bd4f elementor-widget elementor-widget-heading\" data-id=\"1a7bd4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quality management<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f09babd elementor-widget elementor-widget-text-editor\" data-id=\"f09babd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Companies wishing to place medical devices on the European market must establish, document, implement and maintain a quality management system (QMS) in accordance with the legal requirements for the manufacture of their products. The quality management system should be appropriate to the risk class and type of device and should ensure compliance with the requirements of the MDR. The requirements for a quality management system for medical device manufacturers are defined by the EN ISO 13485 standard &#8220;Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes&#8221;.<\/p>\n<p>We advise and accompany you in the implementation, maintenance or revision of a quality management system in accordance with DIN EN ISO 13485. Please feel free to contact us if you have any questions about QMS!<\/p>\n\t\t\t\t\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-inner-column elementor-element elementor-element-540217a\" data-id=\"540217a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e2e2c4 elementor-widget elementor-widget-image\" data-id=\"2e2e2c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"512\" height=\"512\" src=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512.png\" class=\"attachment-full size-full wp-image-5291\" alt=\"\" srcset=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512.png 512w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-300x300.png 300w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-100x100.png 100w, https:\/\/mec-abc.de\/wp-content\/uploads\/2020\/10\/kompass-512-150x150.png 150w\" sizes=\"(max-width: 512px) 100vw, 512px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Quality management REGULATORY AFFAIRS under MDR Quality management Companies wishing to place medical devices on the European market must establish, document, implement and maintain a quality management system (QMS) in accordance with the legal requirements for the manufacture of their products. The quality management system should be appropriate to the risk class and type of [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":0,"parent":6050,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5404","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/comments?post=5404"}],"version-history":[{"count":8,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5404\/revisions"}],"predecessor-version":[{"id":6245,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5404\/revisions\/6245"}],"up":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/6050"}],"wp:attachment":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/media?parent=5404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}