{"id":241,"date":"2024-02-27T20:20:50","date_gmt":"2024-02-27T23:20:50","guid":{"rendered":"https:\/\/sitemakers.com.br\/bm\/?page_id=241"},"modified":"2024-03-05T06:53:49","modified_gmt":"2024-03-05T09:53:49","slug":"mdsap-consulting","status":"publish","type":"page","link":"https:\/\/sitemakers.com.br\/bm\/index.php\/mdsap-consulting\/","title":{"rendered":"MDSAP Consulting"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"241\" class=\"elementor elementor-241\" 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\">MDSAP 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>Das\u00a0<b>Medical Device Single Audit Program MDSAP<\/b>\u00a0ist ein von verschiedenen Beh\u00f6rden anerkanntes Auditprogramm, welches von Audit-Organisationen\u00a0 durchgef\u00fchrt wird. Ziel des MDSAP ist es, in einem Audit die Anforderungen verschiedener internationaler Zulassungsbeh\u00f6rden im Medizinproduktebereich abzudecken.\u00a0\u00a0<\/p><h3><b>Teilnehmer am MDSAP-Programm:\u00a0<\/b><\/h3><p>\u00a0<\/p><table><tbody><tr><td><p><b>Land<\/b><\/p><\/td><td><p><b>Beh\u00f6rde<\/b><\/p><\/td><td><p><b>QM-Vorgaben<\/b><\/p><\/td><\/tr><tr><td><p>Australien<\/p><\/td><td><p>Therapeutic Goods Administration TGA<\/p><\/td><td><p>Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)<\/p><\/td><\/tr><tr><td><p>Brasilien<\/p><\/td><td><p>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA)<\/p><\/td><td><p>Brazilian Good Manufacturing Practices (RDC ANVISA 16\/2013)<\/p><\/td><\/tr><tr><td><p>Kanada<\/p><\/td><td><p>Health Canada<\/p><\/td><td><p>ISO 13485:2016<\/p><\/td><\/tr><tr><td><p>Japan<\/p><\/td><td><p>Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)<\/p><\/td><td><p>Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)<\/p><\/td><\/tr><tr><td><p>USA<\/p><\/td><td><p>Food and Drug Administration FDA<\/p><\/td><td><p>QSR \u2013 21 CFR Part 820<\/p><\/td><\/tr><\/tbody><\/table>\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=\"388\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/mdsap.jpg\" class=\"attachment-large size-large wp-image-344\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/mdsap.jpg 700w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/mdsap-300x166.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>MDSAP Consulting Das\u00a0Medical Device Single Audit Program MDSAP\u00a0ist ein von verschiedenen Beh\u00f6rden anerkanntes Auditprogramm, welches von Audit-Organisationen\u00a0 durchgef\u00fchrt wird. Ziel des MDSAP ist es, in einem Audit die Anforderungen verschiedener internationaler Zulassungsbeh\u00f6rden im Medizinproduktebereich abzudecken.\u00a0\u00a0 Teilnehmer am MDSAP-Programm:\u00a0 \u00a0 Land Beh\u00f6rde QM-Vorgaben Australien Therapeutic Goods Administration TGA Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) [&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-241","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/241","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=241"}],"version-history":[{"count":7,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/241\/revisions"}],"predecessor-version":[{"id":347,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/241\/revisions\/347"}],"wp:attachment":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/media?parent=241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}