{"id":1863,"date":"2026-08-13T16:32:01","date_gmt":"2026-08-13T16:32:01","guid":{"rendered":"https:\/\/www.archimedline.com\/?page_id=1863"},"modified":"2026-08-14T17:13:49","modified_gmt":"2026-08-14T17:13:49","slug":"archimedline-eu-qms-certification-in-accordance-with-the-ivdr","status":"publish","type":"post","link":"https:\/\/www.archimedline.com\/en\/archimedline-eu-qms-certification-in-accordance-with-the-ivdr\/","title":{"rendered":"ARCHImedline: EU QMS certification in accordance with the IVDR"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">ARCHImedline erreicht einen wichtigen regulatorischen Meilenstein: Unser Qualit\u00e4tsmanagementsystem wurde durch die Benannte Stelle <strong>QMD Services GmbH (NB 2962)<\/strong> gem\u00e4\u00df der Verordnung (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) bewertet und zertifiziert.<\/p>\n\n<p class=\"wp-block-paragraph\">Das EU Quality Management System Certificate basiert auf <strong>Anhang IX, Kapitel I und III<\/strong> der IVDR. Damit unterliegt unser Qualit\u00e4tsmanagementsystem der laufenden \u00dcberwachung durch die Benannte Stelle und erf\u00fcllt die Anforderungen f\u00fcr eine verl\u00e4ssliche, regelkonforme Entwicklung und Bereitstellung von In-vitro-Diagnostika.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"bereit-fr-klasse-b-ivds\">Bereit f\u00fcr Klasse-B-IVDs<\/h2>\n\n<p class=\"wp-block-paragraph\">Mit der Zertifizierung ist ARCHImedline berechtigt, In-vitro-Diagnostika der <strong>Risikoklasse B<\/strong> gem\u00e4\u00df IVDR-Konformit\u00e4tsbewertungsverfahren auf dem europ\u00e4ischen Markt in Verkehr zu bringen. Die Voraussetzungen nach Anhang IX, Kapitel I und II, sind erf\u00fcllt.<\/p>\n\n<p class=\"wp-block-paragraph\">Unser erster Test hat bereits die CE-IVDR-Kennzeichnung gem\u00e4\u00df Verordnung (EU) 2017\/746 erhalten. Dies steht f\u00fcr ein nach IVDR bewertetes Qualit\u00e4tsmanagement, regulatorische Compliance und einen wichtigen Schritt bei der Bereitstellung zuverl\u00e4ssiger diagnostischer L\u00f6sungen.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"grundlage-fr-innovation\">Grundlage f\u00fcr Innovation<\/h2>\n\n<p class=\"wp-block-paragraph\">Die IVDR-Zertifizierung ist ein entscheidender Schritt f\u00fcr ARCHImedline und unsere Partner. Sie schafft die regulatorische Grundlage, weitere innovative Diagnostikl\u00f6sungen nach IVDR f\u00fcr den europ\u00e4ischen Markt zu entwickeln und bereitzustellen.<\/p>\n\n<p class=\"wp-block-paragraph\">Wir danken unserem Team und allen Partnern f\u00fcr ihre Kompetenz, ihr Engagement und ihre Unterst\u00fctzung auf diesem Weg. Gemeinsam setzen wir unseren Anspruch fort, hochwertige L\u00f6sungen f\u00fcr die Labor- und klinische Diagnostik zu entwickeln.<\/p>\n\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"460\" height=\"200\" src=\"https:\/\/www.archimedline.com\/wp-content\/uploads\/REGLOGO_zertifiziert_farbe.png\" alt=\"\" class=\"wp-image-1866\" style=\"width:367px;height:auto\" srcset=\"https:\/\/www.archimedline.com\/wp-content\/uploads\/REGLOGO_zertifiziert_farbe.png 460w, https:\/\/www.archimedline.com\/wp-content\/uploads\/REGLOGO_zertifiziert_farbe-300x130.png 300w\" sizes=\"auto, (max-width: 460px) 100vw, 460px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ARCHImedline erreicht einen wichtigen regulatorischen Meilenstein: Unser Qualit\u00e4tsmanagementsystem wurde durch die Benannte Stelle QMD Services GmbH (NB 2962) gem\u00e4\u00df der Verordnung (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) bewertet und zertifiziert. Das EU Quality Management System Certificate basiert auf Anhang IX, Kapitel I und III der IVDR. Damit unterliegt unser Qualit\u00e4tsmanagementsystem der laufenden \u00dcberwachung durch die Benannte [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[34,31,32],"tags":[],"class_list":["post-1863","post","type-post","status-publish","format-standard","hentry","category-ivdr-2","category-lc-ms-ms-2","category-peth-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ARCHImedline: EU QMS certification in accordance with the IVDR - ARCHImedline<\/title>\n<meta name=\"description\" content=\"ARCHImedline has reached the EU QMS certificate (IVDR) allowing Class B in vitro diagnostic medical device be placed on the market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.archimedline.com\/en\/archimedline-eu-qms-certification-in-accordance-with-the-ivdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ARCHImedline: EU QMS certification in accordance with the IVDR - 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