{"id":7032,"date":"2023-09-08T11:39:45","date_gmt":"2023-09-08T09:39:45","guid":{"rendered":"https:\/\/mec-abc.de\/fallbericht-dental-implantat\/"},"modified":"2023-09-12T10:28:31","modified_gmt":"2023-09-12T08:28:31","slug":"case-report-dental-implant","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/case-report-dental-implant\/","title":{"rendered":"Case Report: Dental Implant"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7032\" class=\"elementor elementor-7032 elementor-6880\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-cb01c4d elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"cb01c4d\" 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-db08731\" data-id=\"db08731\" 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-5c60024 elementor-section-content-top elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c60024\" 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-4325872\" data-id=\"4325872\" 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-2b602d5 elementor-widget elementor-widget-heading\" data-id=\"2b602d5\" 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\">Case Report Dental Implant<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f5427e8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f5427e8\" 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-11f9fe8 elementor-widget elementor-widget-heading\" data-id=\"11f9fe8\" 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\">Objective<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-809d35e elementor-widget elementor-widget-text-editor\" data-id=\"809d35e\" 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>Our client is a medium-sized, leading manufacturer of dental implants. Our goal was to identify clinical data gaps early on and to get the clinical evaluation through the assessment with as few intermediate steps as possible. This case report describes our approach to early stocktaking in the area of clinical data for implants.<\/p><h3>Our Solution<\/h3><p><strong>Analysis of the Current Situation<\/strong>: We reviewed the basic clinical data such as intended purpose, indications, target patient groups, and clinical benefit information. This helped us to adjust possible formulations to the MDR requirements at an early stage.<\/p><p><strong>Determination of the Clinical Data Situation:<\/strong> At the beginning, we conducted a thorough analysis of the existing clinical data. These were then compared with the basic clinical data. At this point, with our support, indications or details for which only few clinical data were available could already be put to the economic test.<\/p><p><strong>Determination of Requirements:<\/strong> From a regulatory perspective, the safety and performance of medical devices must be comparable to those of similar products. The data on similar products from the state of the Art were analyzed, and the requirements for the customer&#8217;s product were derived.<\/p>\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-e198088\" data-id=\"e198088\" 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-9ccd597 elementor-widget elementor-widget-image\" data-id=\"9ccd597\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;],&quot;sticky_offset&quot;:120,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2.png\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"Instagram Post Fakten Wasser (2)\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6Njk5NSwidXJsIjoiaHR0cHM6XC9cL21lYy1hYmMuZGVcL3dwLWNvbnRlbnRcL3VwbG9hZHNcLzIwMjNcLzA5XC9JbnN0YWdyYW0tUG9zdC1GYWt0ZW4tV2Fzc2VyLTIucG5nIn0%3D\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2.png\" class=\"attachment-full size-full wp-image-6995\" alt=\"\" srcset=\"https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2.png 1080w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-300x300.png 300w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-1024x1024.png 1024w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-150x150.png 150w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-768x768.png 768w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-600x600.png 600w, https:\/\/mec-abc.de\/wp-content\/uploads\/2023\/09\/Instagram-Post-Fakten-Wasser-2-100x100.png 100w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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<div class=\"elementor-element elementor-element-9573c8a e-flex e-con-boxed e-con e-parent\" data-id=\"9573c8a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9ea57bf elementor-widget elementor-widget-heading\" data-id=\"9ea57bf\" 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\">Result<\/h2>\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-cca65b7 e-flex e-con-boxed e-con e-parent\" data-id=\"cca65b7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-be4e965 e-flex e-con-boxed e-con e-parent\" data-id=\"be4e965\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-de61485 elementor-widget elementor-widget-text-editor\" data-id=\"de61485\" 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>Our client already had the certainty during the preparation of the MDR certification if they needed clinical data within the framework of clinical studies and if so, which data should be collected. Through our strategic support, economic decisions could be made on a solid basis. This saved both money and time. Internal processes and resources could be planned well.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\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-3ef42a3 e-flex e-con-boxed e-con e-parent\" data-id=\"3ef42a3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bc166c9 e-flex e-con-boxed e-con e-parent\" data-id=\"bc166c9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6ac0b30 elementor-widget elementor-widget-heading\" data-id=\"6ac0b30\" 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\">At a glance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c645ce elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"5c645ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Early stocktaking<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Strategic support<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Solid foundation<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M173.898 439.404l-166.4-166.4c-9.997-9.997-9.997-26.206 0-36.204l36.203-36.204c9.997-9.998 26.207-9.998 36.204 0L192 312.69 432.095 72.596c9.997-9.997 26.207-9.997 36.204 0l36.203 36.204c9.997 9.997 9.997 26.206 0 36.204l-294.4 294.401c-9.998 9.997-26.207 9.997-36.204-.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Saving of money and time.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Case Report Dental Implant Objective Our client is a medium-sized, leading manufacturer of dental implants. Our goal was to identify clinical data gaps early on and to get the clinical evaluation through the assessment with as few intermediate steps as possible. This case report describes our approach to early stocktaking in the area of clinical [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7032","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/7032","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\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/comments?post=7032"}],"version-history":[{"count":11,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/7032\/revisions"}],"predecessor-version":[{"id":7092,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/7032\/revisions\/7092"}],"wp:attachment":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/media?parent=7032"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}