{"id":30340,"date":"2022-11-17T11:56:41","date_gmt":"2022-11-17T10:56:41","guid":{"rendered":"https:\/\/artiqo.de\/mdr-certification-artiqo-prepares-for-the-future\/"},"modified":"2023-03-20T11:27:15","modified_gmt":"2023-03-20T10:27:15","slug":"mdr-certification-artiqo-prepares-for-the-future","status":"publish","type":"post","link":"https:\/\/artiqo.de\/en\/mdr-certification-artiqo-prepares-for-the-future\/","title":{"rendered":"MDR certification &#8211; ARTIQO prepares for the future"},"content":{"rendered":"<div class=\"wpb-content-wrapper\" id=\"wpb-content-root\"><p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; z_index=&#8221;&#8221;][vc_column width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1613035748057{margin-bottom: 30px !important;}&#8221;][vc_single_image image=&#8221;30114&#8243; img_size=&#8221;full&#8221; qode_css_animation=&#8221;&#8221;][vc_column_text css=&#8221;.vc_custom_1668769121696{padding-bottom: 10px !important;}&#8221;]<span style=\"color: #999999;\"><span class=\"HwtZe\" lang=\"en\"><span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">From left to right<\/span><\/span> <span class=\"jCAhz ChMk0b\"><span class=\"ryNqvb\">the ARTIQO quality team:<\/span><\/span><\/span> Achim Poos, Lukas Lehmann, Dr. Heidrun Jablonski, Mario Frank<\/span>[\/vc_column_text][vc_separator type=&#8221;transparent&#8221; thickness=&#8221;1&#8243; up=&#8221;30&#8243;][vc_column_text css=&#8221;.vc_custom_1670244761540{padding-bottom: 10px !important;}&#8221;]<\/p>\n<h1>MDR certification &#8211; ARTIQO prepares for the future<\/h1>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1668682581057{padding-bottom: 10px !important;}&#8221;]The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. ARTIQO has now cleared the first hurdle. Our certification audit according to DIN EN ISO 13485:2021 took place in September. This current version of the standard represents the connection between the contents of EN ISO 13485:2016 and the essential safety and performance requirements of the EU 2017\/745 (MDR) regulation on medical devices. In preparation for our certification, we were able with the full commitment of the entire team raise our quality management system to the new legal regulations of Annex 2021 and the requirements of the MDR and thus complete the audit with great success.[\/vc_column_text][vc_separator type=&#8221;transparent&#8221; thickness=&#8221;1&#8243; up=&#8221;30&#8243;][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;.vc_custom_1668690879043{padding-bottom: 10px !important;}&#8221;]<\/p>\n<h3>Welcome to the team,<br \/>\nLukas Lehmann<\/h3>\n<p>In preparing for certification, we also had the support of our newest team member. Lukas Lehmann has been strengthening our QM department in his position as quality manager since May 2022. As a qualified biologist, Mr. Lehmann was previously employed in hygiene and cleaning research. There he was able to gain experience that enabled him to quickly familiarize himself with our system and QM-relevant issues.<\/p>\n<p>At ARTIQO, Mr. Lehmann is responsible for the maintenance and further development of the quality management system according to DIN EN ISO 13485 and MDR. He is also responsible for monitoring and controlling internal processes and conducting internal audits.<\/p>\n<p>For our customers and partners, Mr. Lehmann also acts as a contact person in the area of \u200b\u200bcomplaint management.<\/p>\n<p>We are pleased that Mr. Lehmann has found his way to us and wish him continued success in our team.[\/vc_column_text][vc_separator type=&#8221;transparent&#8221; thickness=&#8221;1&#8243; up=&#8221;30&#8243;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. ARTIQO has now cleared the first hurdle. Our certification audit according to DIN EN ISO 13485:2021 took place in September.<\/p>\n","protected":false},"author":1,"featured_media":30119,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[377,376,353],"tags":[],"class_list":["post-30340","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hip-en","category-home-en","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR certification - ARTIQO prepares for the future - ARTIQO Endoprothetik<\/title>\n<meta name=\"description\" content=\"The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. ARTIQO has now cleared the first hurdle. Our certification audit according to DIN EN ISO 13485:2021 took place in September.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/artiqo.de\/en\/mdr-certification-artiqo-prepares-for-the-future\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR certification - ARTIQO prepares for the future\" \/>\n<meta property=\"og:description\" content=\"The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. ARTIQO has now cleared the first hurdle.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/artiqo.de\/en\/mdr-certification-artiqo-prepares-for-the-future\/\" \/>\n<meta property=\"og:site_name\" content=\"ARTIQO Endoprothetik\" \/>\n<meta property=\"article:published_time\" content=\"2022-11-17T10:56:41+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-20T10:27:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/artiqo.de\/wp-content\/uploads\/2022\/11\/qualitaetsteam-1024x655.jpg\" \/>\n<meta name=\"author\" content=\"Christine\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"MDR certification - ARTIQO prepares for the future\" \/>\n<meta name=\"twitter:description\" content=\"The changeover from the currently applicable MDD to the new MDR directive is a major challenge for all medical technology companies. 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