{"id":203,"date":"2024-02-27T19:49:39","date_gmt":"2024-02-27T22:49:39","guid":{"rendered":"https:\/\/sitemakers.com.br\/bm\/?page_id=203"},"modified":"2024-03-05T06:24:27","modified_gmt":"2024-03-05T09:24:27","slug":"iso-134852016","status":"publish","type":"page","link":"https:\/\/sitemakers.com.br\/bm\/index.php\/qm-systems\/iso-134852016\/","title":{"rendered":"ISO 13485:2016"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"203\" class=\"elementor elementor-203\" 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\">ISO 13485:2016<\/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 ISO 13485:2016 liefert einen effektiven Rahmen zur Erf\u00fcllung der umfangreichen Anforderungen an ein Qualit\u00e4tsmanagementsystem f\u00fcr Medizinprodukte. Sowohl Hersteller als auch Dienstleister k\u00f6nnen damit demonstrieren, dass sie die regulatorischen Anforderungen erf\u00fcllen. Die Norm unterst\u00fctzt die Gestaltung eines Qualit\u00e4tsmanagementsystems, dass es einem Hersteller erm\u00f6glicht, effektive Prozesse zu etablieren und aufrechtzuerhalten.\u00a0<\/p><p>Diese Prozesse gew\u00e4hrleisten eine konsistente Entwicklung, Produktion, Installation und Bereitstellung von Medizinprodukten, die f\u00fcr die bestimmungsgem\u00e4sse Verwendung risikofrei und sicher sind.\u00a0<\/p><p>Wir unterst\u00fctzen Sie bei der Konformit\u00e4t Ihres Qualit\u00e4tsmanagementsystems nach ISO 13485:2016 und machen Sie fit f\u00fcr die Zertifizierung!<\/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\/ISO-13485.jpg\" class=\"attachment-large size-large wp-image-316\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/ISO-13485.jpg 700w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/ISO-13485-300x199.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>ISO 13485:2016 Die ISO 13485:2016 liefert einen effektiven Rahmen zur Erf\u00fcllung der umfangreichen Anforderungen an ein Qualit\u00e4tsmanagementsystem f\u00fcr Medizinprodukte. Sowohl Hersteller als auch Dienstleister k\u00f6nnen damit demonstrieren, dass sie die regulatorischen Anforderungen erf\u00fcllen. Die Norm unterst\u00fctzt die Gestaltung eines Qualit\u00e4tsmanagementsystems, dass es einem Hersteller erm\u00f6glicht, effektive Prozesse zu etablieren und aufrechtzuerhalten.\u00a0 Diese Prozesse gew\u00e4hrleisten eine [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":23,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-203","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/203","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=203"}],"version-history":[{"count":7,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/203\/revisions"}],"predecessor-version":[{"id":319,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/203\/revisions\/319"}],"up":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/23"}],"wp:attachment":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/media?parent=203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}