{"id":9377,"date":"2023-03-29T14:45:26","date_gmt":"2023-03-29T14:45:26","guid":{"rendered":"https:\/\/www.clinomic.ai\/?p=9377"},"modified":"2024-05-22T08:13:57","modified_gmt":"2024-05-22T08:13:57","slug":"highest-safety-for-patients-mona-receives-the-mdr-certification","status":"publish","type":"post","link":"https:\/\/www.clinomic.ai\/de\/2023\/03\/29\/highest-safety-for-patients-mona-receives-the-mdr-certification\/","title":{"rendered":"Highest safety for patients: Mona receives the MDR certification!"},"content":{"rendered":"\n

In February 2023, Clinomic received the MDR-certificate for MonaOS 2. We are proud to be one of the first manufacturers to receive the MDR certificate and we thank our Quality Management and Regulatory Affairs team for their great work! Martin Gr\u00fcterich’s team ensured that Clinomic meets all the requirements for MDR certification. A big thank you also goes to the T\u00dcV S\u00dcD Product Service team for the thorough yet speedy conformity assessment.<\/p>\n\n\n

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Clinomic celebrates the great team achievement of receiving MDR certification<\/figcaption><\/figure>\n<\/div>\n\n\n

The Medical Device Regulation, or „MDR“ for short, is the European Medical Devices Regulation 2017\/745, which came into force in May 2021. The MDR replaced the Medical Device Directive 93\/42\/EEC (MDD). The risk class of MonaOS 2 has also been upgraded from I to IIa. This has once again increased the requirements for MonaOS 2 in terms of safety, performance and documentation.<\/p>\n\n\n

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After the Declaration of Conformity was signed by our CEOs, team members enjoyed a slice of MDR cake!<\/figcaption><\/figure>\n<\/div>\n\n\n

We have once again demonstrated that we meet these high requirements by successfully submitting the MonaOS 2 product file to T\u00dcV S\u00fcd for inspection in March of last year and by passing two further audits of our quality management system in the course of 2022. Mona will continue to support the well-being and safety of patients in the future!<\/p>\n\n\n

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A big \u201ethank you!\u201d goes to our QM\/RA-team (f.l.t.r.: Martin Gr\u00fcterich, Swati Mandekar, Bassam Kamal and Olguta Stanescu)<\/figcaption><\/figure>\n<\/div>\n\n\n
\n\n\n\n

<\/p>\n\n\n\n

DE: <\/strong>H\u00f6chste Sicherheit f\u00fcr Patienten: Mona erh\u00e4lt die MDR-Zertifizierung!<\/p>\n\n\n\n

Im Februar 2023 erhielt Clinomic das MDR-Zertifikat f\u00fcr MonaOS 2. Wir sind stolz, dass wir zu den ersten Herstellern geh\u00f6ren, die das MDR-Zertifikat erhalten haben und danken unserem Quality Management and Regulatory Affairs-Team f\u00fcr Ihre gro\u00dfartige Arbeit! Das Team um Martin Gr\u00fcterich hat daf\u00fcr gesorgt, dass Clinomic alle Anforderungen f\u00fcr die MDR-Zertifizierung erf\u00fcllt. Ein gro\u00dfer Dank geht ebenfalls an das Team des T\u00dcV S\u00dcD Product Service f\u00fcr die gr\u00fcndliche und dennoch z\u00fcgige Pr\u00fcfung.<\/p>\n\n\n\n

Die Medical Device Regulation, kurz \u201eMDR\u201c, ist die Europ\u00e4ische Medizinprodukte-Verordnung 2017\/745, welche im Mai 2021 in Kraft trat. Die MDR l\u00f6ste die Medizinprodukt-Richtlinie 93\/42\/EWG (MDD) ab. In diesem Zuge ist auch die Risikoklasse von MonaOS 2 von I auf IIa hochgestuft worden. Damit sind die Anforderungen an MonaOS 2 bez\u00fcglich Sicherheit, Leistungsf\u00e4higkeit und Dokumentation noch einmal gestiegen.<\/p>\n\n\n\n

Dass wir diese hohen Anforderungen erf\u00fcllen, haben wir nun erneut unter Beweis gestellt, indem wir im M\u00e4rz letzten Jahres dem T\u00dcV S\u00fcd erfolgreich die Produktakte von MonaOS 2 zur Pr\u00fcfung vorgelegt haben und im Laufe des Jahres 2022 zwei weitere Audits unseres Qualit\u00e4tsmanagementsystems bestanden haben. Auch in Zukunft wird Mona das Wohl und die Sicherheit der Patienten und Patientinnen unterst\u00fctzen!<\/p>\n","protected":false},"excerpt":{"rendered":"

In February 2023, Clinomic received the MDR-certificate for MonaOS 2. We are proud to be one of the first manufacturers to receive the MDR certificate and we thank our Quality Management and Regulatory Affairs team for their great work! Martin Gr\u00fcterich’s team ensured that Clinomic meets all the requirements for MDR certification. A big thank […]<\/p>\n

Weiterlesen…<\/a><\/p>\n","protected":false},"author":12,"featured_media":9382,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"iawp_total_views":72,"footnotes":"","_et_pb_custom_css":""},"categories":[13],"tags":[24,95,92,82,142,70,69,221,217,36,220,223,224,55,222,25,258,74],"class_list":["post-9377","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-announcements","tag-clinomic","tag-digitales-krankenhaus","tag-digitalisierung","tag-gesundheitswesen","tag-healthtech","tag-icu","tag-intensive-care","tag-manufacturer-medcial-technology","tag-mdr","tag-medical-technology","tag-medical-technology-certificate","tag-medizinprodukt","tag-medizinproduktemarkt","tag-medtech","tag-medtech-germany","tag-mona","tag-public","tag-telemedizin"],"acf":[],"_et_pb_custom_css":"","yoast_head":"\nHighest safety for patients: Mona receives the MDR certification! - Clinomic<\/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:\/\/www.clinomic.ai\/2023\/03\/29\/highest-safety-for-patients-mona-receives-the-mdr-certification\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Highest safety for patients: Mona receives the MDR certification! - Clinomic\" \/>\n<meta property=\"og:description\" content=\"In February 2023, Clinomic received the MDR-certificate for MonaOS 2. 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