{"id":7097,"date":"2018-05-09T10:20:18","date_gmt":"2018-05-09T08:20:18","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7097"},"modified":"2024-10-29T15:10:41","modified_gmt":"2024-10-29T14:10:41","slug":"ce-certification-support","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/","title":{"rendered":"CE MARKING SUPPORT"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><div><img decoding=\"async\" class=\"size-medium wp-image-7765 alignnone\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/08\/EU-Commission-300x169.jpg\" alt=\"\" width=\"300\" height=\"169\"><\/div>\n<div>&nbsp;<\/div>\n<h4 class=\"fusion-responsive-typography-calculated\" style=\"float: left; width: 70%; --fontsize: 28; line-height: 1.29; --minfontsize: 28;\" data-fontsize=\"28\" data-lineheight=\"36.12px\"><strong>Support to obtain the CE marking for Medical Devices (Ref. MDR (EU) 2017\/745) and IVD (Ref. IVDR (EU) 2017\/746)<\/strong><\/h4>\n<div style=\"float: left; width: 70%;\">\n<p><strong>The right choice for a complex route <\/strong><\/p>\n<p>The path to the EC marking of Medical Devices and IVD requires a thorough and rigorous analysis and preparation of the technical reference documentation.<\/p>\n<p>Thema experts accompany and support Manufacturers in the process of obtaining the CE marking for Medical Devices, IVD products (Rif. MDR (EU) 2017\/745) and IVD (Rif. IVDR (EU) 2017\/746).<\/p>\n<p><strong>Some services: <\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/\"><b>IVDR Emergency Kit: t<span class=\"JsGRdQ\">he fastest solution to respond to the mail obligations of the IVDR (EU) 2017\/746.<\/span><\/b><\/a><\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\"><b>MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices.<\/b><\/a><\/li>\n<li>Feasibility analysis for verification of compliance with safety and efficacy general requirements necessary to obtain the CE marking.<\/li>\n<li><em>Documental Gap-analysis<\/em>\/<em>orientative\/pre-screening <\/em>for the adaptation of the related Technical Documentation of product and system<em>.<\/em><\/li>\n<li>Drafting related Technical Documentation of product and system.<\/li>\n<li>Drafting\/updating Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post Market Clinical Follow up (PMCF).<\/li>\n<li><em>Labelling<\/em> adjustment (labels, instructions for use).<\/li>\n<li>Post-market surveillance process (PMS plan and report, PSUR, trend analysis).<\/li>\n<li>Implementation of MDR and IVD requirements related to post-market surveillance, market surveillance, vigilance and registration obligations of Manufacturer and economic operators during the \u201c<em>period of grace\u201d <\/em>of the CE MDD and IVD certificates.<\/li>\n<li>Support for Medical Software Validation activity.<\/li>\n<\/ul>\n<\/div>\n<div id=\"serviceslist\" style=\"float: left; width: 27%; margin-left: 1.5%; padding-left: 1.5%; border-left: 1px solid;\">\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/ivdr-emergency-kit\/\">IVDR Emergency Kit<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/new-mdr-emergency-kit\/\">MDR Emergency Kit<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">Strategic Regulatory Consulting<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE Marking Support<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/italian-and-european-ministerial-registrations\/\">Italian and European Ministerial Registrations<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">International Registrations outside the EU<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative\/\">Local Representative <\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">Quality and International GMPs<\/a><\/p>\n<\/div>\n<div style=\"float: none; clear: both;\">&nbsp;<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":10312,"parent":9970,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7097","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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