{"id":8341,"date":"2024-05-23T11:35:01","date_gmt":"2024-05-23T09:35:01","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-medical-devices-division-celebrates-successful-inspection-visit\/"},"modified":"2024-05-23T11:38:21","modified_gmt":"2024-05-23T09:38:21","slug":"ecm-medical-devices-division-celebrates-successful-inspection-visit","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-medical-devices-division-celebrates-successful-inspection-visit\/","title":{"rendered":"ECM Medical Devices Division celebrates successful inspection visit"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>Successfully passed by our Medical Devices Division, the inspection<\/em><\/strong><strong> <em>visit by the Italian Ministry of Health and Accredia, according to the MDR Regulation and the MDD Directive.<\/em><\/strong><\/h2>\n\n<p>Recently, the <a href=\"https:\/\/www.entecerma.it\/en\/sectors\/medical-devices\/\" target=\"_blank\" rel=\"noopener\"><strong>ECM Medical Devices Division<\/strong><\/a> received the inspection visit from the Italian Ministry of Health and Accredia. This important audit was conducted according to <strong>Regulation (EU) 2017\/745<\/strong> and<strong> Directive 93\/42\/EEC<\/strong>, in order to assess our ability to operate as a Notified Body.<\/p>\n\n<div style=\"height:23px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-c8249dff51c2cb854be0f73deabf2936\" style=\"color:#085f9b\"><strong>CONFIRMATION OF NOTIFICATION<\/strong><\/h3>\n\n<p><strong>We are thrilled to confirm that ECM successfully passed the inspection! <\/strong>Thanks to this result, we have achieved the re-confirmation of our designation as <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\"><strong>Notified Body No. 1282<\/strong><\/a> to operate in accordance with the <strong>European Medical Device Regulation 2017\/745<\/strong> (MDR). This notification allows us to continue providing conformity assessment services for the issuance of EU certification for medical devices intended for the EU market.<\/p>\n\n<div style=\"height:23px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-bd76c0b9da30d7079138bbba8905c275\" style=\"color:#085f9b\"><strong>AUTHORIZATION AND SURVEILLANCE<\/strong><\/h3>\n\n<p>Furthermore, also our authorisation to operate under the <strong>Medical Device Directive 93\/42\/EEC<\/strong> (MDD) was reconfirmed, allowing us to carry out the required surveillance activities to verify the validity of certificates during the transitional period (for <em>legacy devices<\/em>).<\/p>\n\n<p>For more details on our accreditations and the full list of devices within our scope, please visit the European Commission&#8217;s <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/#\/home\" target=\"_blank\" rel=\"noopener\">Nando Information System database<\/a>.<\/p>\n\n<blockquote class=\"wp-block-quote is-style-default is-layout-flow wp-block-quote-is-layout-flow\"><cite><em>\u201cThanks to the technical and regulatory expertise of our team, we are proud to have achieved these important milestones,&#8221;<\/em> explains our CEO <strong>Luca Bedonni<\/strong> <em>&#8220;the accreditations attest to our professionalism and confirm our role as a reference body for the certification of medical devices within the EU market.\u201d<\/em><\/cite><\/blockquote>\n\n<blockquote class=\"wp-block-quote is-style-default is-layout-flow wp-block-quote-is-layout-flow\"><\/blockquote>\n\n<p><strong>For more information<\/strong> about our services or to contact our team, please send an email to our Sales Manager Diego Stevanella at <a href=\"mailto:diego.s@entecerma.it\" target=\"_blank\" rel=\"noopener\">diego.s@entecerma.it<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Successfully passed by our Medical Devices Division, the inspection visit by the Italian Ministry of&#8230;<\/p>\n","protected":false},"author":2,"featured_media":8335,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[913,128,1166,569,404,123,436],"class_list":["post-8341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-mdr-en","tag-mdr-2017-745-en","tag-mdr-notified-body-en","tag-medical-device-certification-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-organismo-notificato-1282-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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