{"id":9295,"date":"2020-05-18T13:43:00","date_gmt":"2020-05-18T11:43:00","guid":{"rendered":"https:\/\/mbits.info\/?p=9295"},"modified":"2022-05-11T11:11:25","modified_gmt":"2022-05-11T09:11:25","slug":"mbits-erhaelt-mdr-zertifikat","status":"publish","type":"post","link":"https:\/\/mbits.info\/en\/mbits-erhaelt-mdr-zertifikat","title":{"rendered":"mbits receives MDR certificate"},"content":{"rendered":"<p>As one of the first medical device manufacturers<\/p>\n\n\n\n<p>The original start date for the scope of the new Medical Device Regulation (MDR) EU 2017\/745 was May 26, 2020. Due to the Corona crisis, the new Medical Device Regulation was postponed by a whole year, as a changeover even under regular operation would have presented many medical technology companies with major challenges, which they did not want to be additionally burdened with during the exceptional situation caused by Covid-19.<\/p>\n\n\n\n<p class=\"translation-block\">mbits had already converted its quality management to MDR before the Corona crisis. The just released new version of our app mRay 6.0 has already been developed according to MDR guidelines without exception.<\/p>\n\n\n\n<p class=\"translation-block\">The changeover requires some fundamental adjustments to existing workflows - a major challenge. The immediate assistance program of the <a href=\"https:\/\/www.gesundheitsindustrie-bw.de\/mdr-soforthilfe\" target=\"_self\">Health Industry BW<\/a> works with companies to develop group-specific content and make it available.<\/p>","protected":false},"excerpt":{"rendered":"<p>Als einer der ersten Medizinprodukte-Hersteller Ursrp\u00fcnglich war der 26. Mai 2020 Starttermin des Geltungsbereichs der neuen Medical Device Regulation (MDR) EU 2017\/745. Auf Grund der Corona-Krise wurde die neue Verordnung \u00fcber Medizinprodukte um ein ganzes Jahr verschoben, da eine Umstellung auch unter Regelbetrieb viele Medizintechnik-Unternehmen vor gro\u00dfe Herausforderungen gestellt h\u00e4tte, die man ihnen w\u00e4hrend der [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12392,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[320,1,49],"tags":[53,208,209,52],"class_list":["post-9295","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all","category-news","category-presse","tag-mbits","tag-mdr","tag-medizinprodukt","tag-mray"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>mbits erh\u00e4lt MDR-Zertifikat - mbits<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mbits.info\/en\/mbits-erhaelt-mdr-zertifikat\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"mbits erh\u00e4lt MDR-Zertifikat - mbits\" \/>\n<meta property=\"og:description\" content=\"Als einer der ersten Medizinprodukte-Hersteller Ursrp\u00fcnglich war der 26. Mai 2020 Starttermin des Geltungsbereichs der neuen Medical Device Regulation (MDR) EU 2017\/745. 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