{"id":1515,"date":"2023-02-10T13:19:58","date_gmt":"2023-02-10T12:19:58","guid":{"rendered":"https:\/\/www.joanneum.at\/health\/?p=1515"},"modified":"2024-05-02T16:55:35","modified_gmt":"2024-05-02T14:55:35","slug":"mdr-compliance","status":"publish","type":"post","link":"https:\/\/www.joanneum.at\/health\/en\/mdr-compliance\/","title":{"rendered":"MDR compliance"},"content":{"rendered":"<p>We have made it! Our current quality management system in accordance with EN ISO 13485 and our Class IIa medical device, the open-flow microperfusion catheter and its accessories, have successfully completed the transition to the new EU Medical Device Regulation (MDR).<\/p>\n<p>We would like to thank all employees for their commitment and patience in achieving this important regulatory milestone at the HEALTH Institute.<\/p>\n<p>&nbsp;<\/p>\n<h3>You can find our current certificates here:<\/h3>\n<p>English: <a href=\"https:\/\/www.joanneum.at\/wp-content\/uploads\/2024\/09\/2022_mdc_Zertifikat_EN-ISO-13485-2016_D4004700007_ENGLISH_sig.pdf\" target=\"_blank\" rel=\"noopener\">EN-ISO-13485-2016_ENGLISH<\/a><\/p>\n<p>German: <a href=\"https:\/\/www.joanneum.at\/health\/wp-content\/uploads\/sites\/4\/2024\/05\/2022_mdc_Zertifikat_EN-ISO-13485-2016_D4004700007_DEUTSCH_sig.pdf\" target=\"_blank\" rel=\"noopener\">EN-ISO-13485-2016 DEUTSCH<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Wir haben es geschafft! Unser aktuelles Qualit\u00e4tsmanagementsystem nach EN ISO 13485 sowie unser Medizinprodukt der Klasse IIa, der Open-Flow-Mikroperfusionskatheter und dessen Zubeh\u00f6r, haben die Umstellung auf die neue EU-Medizinprodukteverordnung (MDR) erfolgreich absolviert. Wir m\u00f6chten uns bei allen Mitarbeitenden f\u00fcr ihren Einsatz und ihre Geduld bedanken, um diesen wichtigen regulatorischen Meilenstein am Institut HEALTH zu erreichen. [&hellip;]<\/p>\n","protected":false},"author":40,"featured_media":1518,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[44,45],"class_list":["post-1515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-allgemein","tag-qualitaetsmanagement","tag-zertifizierung","institutes-health","business_areas-gesundheit-und-pflege"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/posts\/1515","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/users\/40"}],"replies":[{"embeddable":true,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/comments?post=1515"}],"version-history":[{"count":5,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/posts\/1515\/revisions"}],"predecessor-version":[{"id":7166,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/posts\/1515\/revisions\/7166"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/media\/1518"}],"wp:attachment":[{"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/media?parent=1515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/categories?post=1515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.joanneum.at\/health\/en\/wp-json\/wp\/v2\/tags?post=1515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}