} #block-ivt_user-non_member_newsletter_full, color: rgba(0,0,0,0); content: "The"; display: inline-block; position: absolute; MDR Application Procedure. } .view-home-page-highlighted .views-field-title { margin:20px auto 30px auto; width:100%; text-align:center; } Contact us color: #0055a5; text-shadow: 0 0 .03125em rgba(0,85,165,.3); You can continue shopping or proceed to checkout. background: -webkit-linear-gradient(-45deg, #e8cc89 0%,#ffffff 50%,#e8cc89 100%); .reg-button:active, .reg-button:hover { background: #E82A33; } } } To conform to Annex I of MDR 2017/745, a GSPR checklist is a mandatory document and is one of the most fundamental pre-conditions to put any medical device on the EU market. .page-admin #page { .sf-menu.sf-horizontal.sf-shadow UL, .sf-menu.sf-vertical.sf-shadow UL, .sf-menu.sf-navbar.sf-shadow UL UL, .sf-menu.sf-style-default LI LI { background:none; border-radius:0; } margin: 0 10px 7px 0; max-height: none; max-width: 40%; } As you are aware, the European medical device industry will undergo significant change as a result of the new medical device regulations. background: #fff url('/sites/default/files/images/upload/white-paper-ivt.png') center center no-repeat; background-size: contain; Make sure you and your business are compliant with the new EU MDR. However, for our purposes, a gap analysis is the most proactive and low-cost method that allows MedTech companies to maintain the efficacy of their quality systems. font-size: inherit; font-style: normal; font-weight: 400; font-size: 16px; line-height: 1.25; #page .content .space { color: #e82a33; text-shadow: 0 0 .03125em rgba(232,42,51,.2); Key Benefits : Covers all #page .content blockquote P:nth-of-type(2) { You can, 16th Annual Product Complaints Congress for Life Sciences. #header-inner.container .five.columns { display: none !important; .view-rgi-journal-article-list .views-field-title span a, body.user-dashboard .views-field-title a, Designed to be easy to use and follow, the template will save … This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745 . What are the important timelines for transitioning to the European MDR? margin: .375em auto; padding: .5em 0; position: relative; background: #e8cc89; Brian Burns CEO, Validant. background: #fff; How to comply with the EU-MDR If you are going to claim compliance with the EU-MDR there is no real alternative to becoming familiar with it one's self. With May 2020 around the corner, we understand that a clear understanding of the most critical items to address is crucial and have compiled an EU MDR checklist with actionable technical documentation requirements. border: 1px solid #7d7f77; padding: 0 10px; vertical-align: top; } font-family: Open Sans, sans-serif; #superfish-1 LI A, #superfish-1 LI.first A.sf-depth-1, #superfish-1 LI.last A.sf-depth-1, #superfish-1 LI A.sf-with-ul { #header-inner.container .four.columns { background:url('/sites/default/files/IVT-Network-white.png?3') no-repeat center center; .form-button-wrapper, li.button a, a.button, ul.links li.comment_add { } var $link = $('#iphorm_fancybox_6010485a88e08'); The assessment results are gathered in a master impact matrix, making it possible to prepare overviews showing the impacts from different angles, e.g. background-image: linear-gradient(to bottom, rgba(255,255,255,0) 0%,rgba(153,153,153,0) 40%,rgba(102,102,102,0) 60%,rgba(0,0,0,0.15) 100%); #page ARTICLE TABLE THEAD TR:first-of-type TD P { margin: 10px 0; } If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.. 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