{"id":1953,"date":"2020-09-16T10:30:00","date_gmt":"2020-09-16T08:30:00","guid":{"rendered":"https:\/\/www.entecerma.it\/new-mdr-2017-745-ecm-increases-its-competences\/"},"modified":"2020-09-21T15:29:19","modified_gmt":"2020-09-21T13:29:19","slug":"new-mdr-2017-745-ecm-increases-its-competences","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/new-mdr-2017-745-ecm-increases-its-competences\/","title":{"rendered":"New MDR 2017\/745: ECM increases its competences"},"content":{"rendered":"\n<p>Next 29-30 September 2020, our Technical Expert\u00a0<em>Tatiana Vignudelli<\/em>\u00a0will attend as speaker at the\u00a0<strong>Technical Documentation Training<\/strong>\u00a0organized in Bruxelles by\u00a0<strong>Team-NB<\/strong>, the association that brings together the major European Notified Bodies for medical devices.&#13;\n&#13;\nThe meeting is an opportunity for the training and alignment among the notified bodies on the subject of the technical documentation assessment of medical devices, according to the<strong>\u00a0Regulation (MDR) 2017\/745<\/strong>.<\/p>\n\n<p>As well as helping notified bodies to address the new requirements of technical documentation in their assessments, the meeting encourages discussion and feedback among participants, in order to promote a better harmonization on shared issues. <\/p>\n\n<p>As Notified Body for the <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-directive-1993-42-ec\/\">MDD 93\/42\/EEC Directive<\/a>,\u00a0<strong>Ente Certificazione Macchine<\/strong>\u00a0is an active member of\u00a0<a href=\"https:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>Team-NB<\/strong><\/a>\u00a0&#8211; the\u00a0<em>European Association of Notified Bodies for Medical Devices<\/em>\u00a0founded in 2001, which currently includes 24 members from 14 different countries. The aim of the association is to promote transparency and communication between Notified Bodies, in order to guarantee a continuous updating and dialogue on regulatory matter.<\/p>\n\n<p>Being part of such an international association and being called as speakers to bring its contribution and experience is a great\u00a0<strong>prestige<\/strong>\u00a0for Ente Certificazione Macchine, as well as a unique opportunity of interaction with highly competent interlocutors.<\/p>\n\n<p>ECM keeps on its road to achieve at the soonest the accreditation as Notified Body for MDR Regulation 2017\/745, while continuing to carry out the certification activities in accordance with MDD 93\/42\/EEC.&#13;\n<strong>For information<\/strong>\u00a0about our services: Sales Manager ECM\u00a0<em>Antonio Balassone\u00a0<\/em>&#8211;\u00a0<a href=\"http:\/\/antonio@entecerma.it\/\">antonio@entecerma.it<\/a>\u00a0| mob. +39 393 2471040<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Next 29-30 September 2020, our Technical Expert\u00a0Tatiana Vignudelli\u00a0will attend as speaker at the\u00a0Technical Documentation Training\u00a0organized&#8230;<\/p>\n","protected":false},"author":2,"featured_media":1951,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13,2],"tags":[23,17,24,20],"class_list":["post-1953","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","category-news","tag-dispositivimedici","tag-mdr745","tag-organismonotificato","tag-teamnb"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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