{"id":6609,"date":"2015-02-20T20:12:45","date_gmt":"2015-02-20T19:12:45","guid":{"rendered":"https:\/\/digiterm.hu\/qualitaet-und-sicherheit\/"},"modified":"2024-10-06T23:37:55","modified_gmt":"2024-10-06T21:37:55","slug":"qualitaet-und-sicherheit","status":"publish","type":"page","link":"https:\/\/digiterm.hu\/de\/qualitaet-und-sicherheit\/","title":{"rendered":"Qualit\u00e4t und Sicherheit"},"content":{"rendered":"

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EU-VERORDNUNG \u00dcBER MEDIZINPRODUKTE<\/h2><\/div>

Die neue Medizinprodukteverordnung 2017\/745 (MDR)<\/strong> trat in der EU am 26. Mai 2021 in Kraft. Alle Medizinprodukte, die unter die Klasse I fallen, m\u00fcssen vom ersten Tag an der MDR entsprechen. Die meisten unserer Lehrst\u00fchle geh\u00f6ren zu dieser Gruppe.<\/p>\n

Wir freuen uns, Ihnen mitteilen zu k\u00f6nnen, dass Digiterm die Vorbereitungsphase abgeschlossen hat und nun MDR-konform ist.<\/p>\n

Akteur-ID\/SRN : HU-MF-000004201<\/strong><\/p>\n

Digiterm auf der EDUAMED-Liste der Wirtschaftsbeteiligten<\/a><\/p>\n

Digterm-Produkte auf EDUAMED<\/a><\/p>\n<\/div><\/div><\/div>

Als Folge der Registrierung werden einige \u00c4nderungen auf den Etiketten der St\u00fchle sichtbar sein. Diese enthalten die UDI-DI-Kennung des Stuhltyps und die Bezeichnung des Stuhls in der Landessprache des Bestimmungsortes.<\/p>\n

W\u00e4hrend wir weltweit sichere und qualitativ hochwertige Sitzl\u00f6sungen liefern, war und ist die Zufriedenheit unserer Partner immer der wichtigste Wert f\u00fcr uns.<\/p>\n

Wenn Sie Fragen zum Qualit\u00e4tsmanagement haben, wenden Sie sich bitte an unser QMS & EMS-Team:<\/strong><\/p>\n

E-Mail: quality@digiterm.hu<\/a><\/p>\n

Kontakt <\/i><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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<\/a>Qualit\u00e4tsmanagement-System<\/h2><\/span>
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Um unsere Ziele zu erreichen, halten wir die ISO 9001:2015<\/strong> f\u00fcr die Produkt- und Dienstleistungsqualit\u00e4t und die EN ISO 13485:2016<\/strong> speziell f\u00fcr die Qualit\u00e4t von Medizinprodukten ein.<\/p>\n

Die \u00dcbereinstimmung mit den Anforderungen der Standards wird regelm\u00e4\u00dfig \u00fcberpr\u00fcft.<\/p>\n

ISO 9001:2015 Qualit\u00e4tsmanagementsystem
\n<\/strong>Reg. Nr.: C603179
\nDatum des Ablaufs: 03.09.2026<\/p>\n

Zertifikat ansehen<\/a><\/h3>\n

ISO 13485:2016 Qualit\u00e4tsmanagementsystem
\n<\/strong>Reg. Nr.: 145207
\nDatum des Ablaufs: 06.09.2026<\/p>\n

Zertifikat ansehen<\/a><\/h3>\n<\/div><\/div><\/div>
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Umweltmanagement-System<\/h2><\/span>
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Die Gesch\u00e4ftsleitung von Digiterm Ltd. hat sich – in \u00dcbereinstimmung mit den Anforderungen der Norm ISO 14001:2015<\/strong> – zur kontinuierlichen Verbesserung der Umweltleistung und zur Vermeidung von Umweltverschmutzung verpflichtet.<\/p>\n

Die \u00dcbereinstimmung mit den Anforderungen der Standards wird regelm\u00e4\u00dfig \u00fcberpr\u00fcft.<\/p>\n

ISO 14001:2015 Umweltmanagementsystem
\n<\/strong>Reg. Nr.: 24081586KIR
\n<\/strong>Datum des Ablaufs: 14.09.2027<\/strong><\/p>\n

Zertifikat ansehen<\/a><\/h3>\n<\/div><\/div><\/div>
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FDA-Ger\u00e4te-Registrierung und -Listung<\/span><\/b><\/h2><\/h2><\/span>
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\n<\/td>\n

Die Produkte von Digiterm fallen in eine generische Kategorie von ausgenommenen Produkten der Klasse I gem\u00e4\u00df der Definition in 21 CFR Parts 862-892. Daher ist vor der Vermarktung des Produkts in den USA kein Antrag auf Vorabanmeldung und keine FDA-Zulassung erforderlich.<\/span><\/p>\n

Als Hersteller muss Digiterm jedoch seine Niederlassung registrieren lassen:<\/span><\/p>\n

Die FDA-Anlagenregistrierung von Digiterm finden Sie hier<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

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<\/a>SFDA-Zertifikat<\/h2><\/h2><\/span>
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\n\n\n
\n

\"\"<\/p>\n<\/td>\n

Digiterm Ltd. ist als Hersteller von Medizinprodukten auch bei der saudischen Lebensmittel- und Arzneimittelbeh\u00f6rde<\/strong> registriert. ( Reg. Nr.: M00370 )<\/p>\n

Die Genehmigung erlaubt die Vermarktung der Comfort St\u00fchle im K\u00f6nigreich Saudi-Arabien.<\/p>\n

Das Zertifikat wird in \u00dcbereinstimmung mit der Medical devices interim regulation (MDIR) und insbesondere mit der Durchf\u00fchrungsbestimmung MDS-IR6 f\u00fcr die Zulassung von Medizinprodukten (MDMA) ausgestellt.<\/p>\n

Zulassungsnummer:<\/strong>MDMA-1-2018-1153
\nAblaufdatum: 26.02.2027.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

<\/div><\/div><\/span>

<\/a>GOST-R Zertifikat<\/h2><\/h2><\/span>
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\n\n\n
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\"\"<\/p>\n<\/td>\n

Digiterm Ltd. ist als Hersteller von medizinischen Ger\u00e4ten auch beim russischen Gesundheitsministerium registriert. (Reg.-Nr.: F33 2012\/11522)<\/p>\n

Die Comfort Therapy St\u00fchle wurden von SGS International Certification Services S. A.<\/strong> getestet und die \u00dcbereinstimmung mit den entsprechenden russischen Normen auf dem GOST-R Zertifikat best\u00e4tigt.<\/p>\n

Zertifikat Nr. POCC HU. IM 24 N Q5939<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div><\/div><\/main>

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DO YOU HAVE QUESTIONS ABOUT OUR PRODUCTS?<\/h2><\/span>
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We work as a united team around the world and give our clients the highest quality products and solutions possible. Our sales team will be happy to help you!<\/h3>\n<\/div>
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Kontakt<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6609","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nQualit\u00e4t und Sicherheit - Digiterm Ltd.<\/title>\n<meta name=\"description\" content=\"Digiterm Dialysis chairs are designed to provide a comfortable and supportive seating arrangement for patients.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/digiterm.hu\/de\/qualitaet-und-sicherheit\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qualit\u00e4t und Sicherheit - Digiterm Ltd.\" \/>\n<meta property=\"og:description\" content=\"Digiterm Dialysis chairs are designed to provide a comfortable and supportive seating arrangement for patients.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/digiterm.hu\/de\/qualitaet-und-sicherheit\/\" \/>\n<meta property=\"og:site_name\" content=\"Digiterm Ltd.\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/digiterm.hu\/\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-06T21:37:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/digiterm.hu\/wp-content\/uploads\/2022\/01\/SFDA_Logo_Digiterm.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"3\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/digiterm.hu\\\/de\\\/qualitaet-und-sicherheit\\\/\",\"url\":\"https:\\\/\\\/digiterm.hu\\\/de\\\/qualitaet-und-sicherheit\\\/\",\"name\":\"Qualit\u00e4t und Sicherheit - 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