{"id":236,"date":"2024-02-27T20:18:02","date_gmt":"2024-02-27T23:18:02","guid":{"rendered":"https:\/\/sitemakers.com.br\/bm\/?page_id=236"},"modified":"2024-03-05T06:49:41","modified_gmt":"2024-03-05T09:49:41","slug":"mdr-2017-745-consulting","status":"publish","type":"page","link":"https:\/\/sitemakers.com.br\/bm\/index.php\/mdr-2017-745-consulting\/","title":{"rendered":"MDR (2017\/745) Consulting"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"236\" class=\"elementor elementor-236\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed4858d e-con-full e-flex e-con e-parent\" data-id=\"ed4858d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2500e8a elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2500e8a\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\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 fetchpriority=\"high\" decoding=\"async\" width=\"1720\" height=\"300\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg\" class=\"attachment-full size-full wp-image-186\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg 1720w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-300x52.jpg 300w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1024x179.jpg 1024w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-768x134.jpg 768w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1536x268.jpg 1536w\" sizes=\"(max-width: 1720px) 100vw, 1720px\" \/>\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>\n\t\t<div class=\"elementor-element elementor-element-68894a7 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"68894a7\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInDown&quot;,&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c73e16b elementor-widget elementor-widget-heading\" data-id=\"c73e16b\" 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 - v3.18.0 - 20-12-2023 *\/\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><h1 class=\"elementor-heading-title elementor-size-default\">MDR (2017\/745) Consulting <\/h1>\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-a9fbb9c e-flex e-con-boxed e-con e-parent\" data-id=\"a9fbb9c\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-10a837d e-con-full e-flex e-con e-child\" data-id=\"10a837d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7902328 animated-slow elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"7902328\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\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<p>Die EU-Verordnung MDR (Medical Device Regulation) 2017\/745 trat\u00a0 am 25. Mai 2017 mit einer urspr\u00fcnglich geplanten \u00dcbergangsfrist von 3 Jahren in Kraft. Die Medical Device Regulation ersetzt die Medical Device Directive (MDD) 93\/42\/EWG.\u00a0<\/p><p>In der Verordnung 2017\/745 gibt es eine Vielzahl von ge\u00e4nderten und neuen Anforderungen, welche es zu implementieren gilt.\u00a0<\/p><p>Dies bezieht sich nicht nur auf die Medizinproduktehersteller selber sondern auch auf weitere Wirtschaftsakteure wie Bevollm\u00e4chtigte (EU-Rep), Importeure oder H\u00e4ndler sowie auch Hersteller von Behandlungseinheiten und Systemen (nach Artikel 22 MDR).\u00a0<\/p><p>Hersteller m\u00fcssen jederzeit in der Lage sein, der zust\u00e4ndigen Beh\u00f6rde die vollst\u00e4ndige technische Dokumentation oder Ausz\u00fcge aus dieser vorzulegen.\u00a0\u00a0<\/p><p>Wir pr\u00fcfen Ihre technische Dokumentation gem\u00e4ss den Anforderungen aus Anhang II \u201cTechnische Dokumentation\u201d sowie Anhang III \u201cTechnische Dokumentation \u00fcber die \u00dcberwachung nach dem Inverkehrbringen\u201d gem\u00e4ss 2017\/745 um Konformit\u00e4t\u00a0 zu erreichen.\u00a0<\/p><p>Wir beraten Sie zum Thema MDR (2017\/745) zu folgenden Themengebieten:\u00a0<\/p><ul><li aria-level=\"1\">Beh\u00f6rden und Benannte Stellen<\/li><li aria-level=\"1\">EUDAMED<\/li><li aria-level=\"1\">\u201cRegulatory Affairs\u201d<\/li><li aria-level=\"1\">Post Market Surveillance (PMS)<\/li><li aria-level=\"1\">Technische Dokumentation (Anhang II und III)\u00a0<\/li><li aria-level=\"1\">Unique Device Identification (UDI)<\/li><li aria-level=\"1\">Sicherheit &amp; Leistung (z.B. IEC 60601:2005)\u00a0<\/li><li aria-level=\"1\">Risikomanagement (z.B. ISO 14971:2019)\u00a0<\/li><li aria-level=\"1\">Qualit\u00e4tsmanagement (z.B. ISO 13485:2016)\u00a0<\/li><li aria-level=\"1\">Gebrauchstauglichkeit (z.B. IED 62366-1:2015)\u00a0<\/li><li aria-level=\"1\">Klinische Bewertung\u00a0<\/li><\/ul><p>\u00a0<\/p><p>Weitere Themen auf Anfrage!<\/p>\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 class=\"elementor-element elementor-element-8657ec9 animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"8657ec9\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"700\" height=\"465\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/eu-mdr.jpg\" class=\"attachment-large size-large wp-image-339\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/eu-mdr.jpg 700w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/eu-mdr-300x199.jpg 300w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ea8728a e-flex e-con-boxed e-con e-parent\" data-id=\"ea8728a\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9b3b1db elementor-widget elementor-widget-spacer\" data-id=\"9b3b1db\" 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 - v3.18.0 - 20-12-2023 *\/\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>.elementor-widget-spacer>.elementor-widget-container{height:100%;width:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer,.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))}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty,.e-con>.elementor-widget-spacer.elementor-widget-empty{position:relative;min-height:22px;min-width:22px}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon,.e-con>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon{position:absolute;top:0;bottom:0;left:0;right:0;margin:auto;padding:0;width:22px;height:22px}<\/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\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDR (2017\/745) Consulting Die EU-Verordnung MDR (Medical Device Regulation) 2017\/745 trat\u00a0 am 25. Mai 2017 mit einer urspr\u00fcnglich geplanten \u00dcbergangsfrist von 3 Jahren in Kraft. Die Medical Device Regulation ersetzt die Medical Device Directive (MDD) 93\/42\/EWG.\u00a0 In der Verordnung 2017\/745 gibt es eine Vielzahl von ge\u00e4nderten und neuen Anforderungen, welche es zu implementieren gilt.\u00a0 Dies [&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":{"footnotes":""},"class_list":["post-236","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/236","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/comments?post=236"}],"version-history":[{"count":7,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/236\/revisions"}],"predecessor-version":[{"id":342,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/236\/revisions\/342"}],"wp:attachment":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/media?parent=236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}