Partner- | Kundenbereich

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Unter Medizinprodukten versteht man alle Instrumente, Geräte, Implantate, Materialien usw., die für die Diagnose, Vorbeugung und Behandlung von Krankheiten beim Menschen bestimmt sind. Sie dienen auch anderen Zwecken, wie beispielsweise der Empfängnisverhütung usw. Diese Produkte unterliegen strengen Vorschriften, die je nach Land, in dem das Produkt vermarktet wird, unterschiedlich sein können. Medizinprodukte werden in folgende Gruppen unterteilt:

Je höher die Risikoklasse und der Invasivitätsgrad, desto wichtiger ist die angemessene Übersetzung. Hier dürfen keine Fehler passieren. Alle damit verbundenen Texte, wie Kennzeichnung und Gebrauchsanweisung, Benutzerhandbücher, Etikettierung, Software, Kataloge oder Broschüren, müssen das Original treu, exakt und präzise wiedergeben. Aus diesem Grund sind unsere Linguisten technische Spezialisten mit nachgewiesener Erfahrung. Hinzu kommt ein umfassender Überarbeitungsprozess entsprechend der Norm ISO 17100, der eine Übersetzung ohne Fehler, Inkonsistenzen oder Ungenauigkeiten gewährleistet.

Zu unseren wichtigsten Kunden im Bereich der Medizinprodukte gehören Hersteller von: Geräten für die Augenchirurgie, Ultraschallgeräten, externen Defibrillatoren, Implantaten für die Traumatologie, Prothesen für die orthopädische Chirurgie, Zahnimplantologie, Geräten für die ästhetische Chirurgie, bildgebenden Diagnosegeräte, chirurgischen Nähten und Netzen, elektromedizinischen Geräten, Elektrostimulatoren für die Physiotherapie, Produkten für die Mundgesundheit, In-vitro Diagnosesystemen, Intrauterinpessaren, nichtinvasiven Überwachungsgeräten u.v.m.
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[av_heading heading=’DOKUMENTE FÜR MEDIZINPRODUKTE‘ tag=’h4′ link_apply=“ link=’manually,http://‘ link_target=“ style=’blockquote modern-quote modern-centered‘ size=“ subheading_active=“ subheading_size=’15‘ margin=“ margin_sync=’true‘ padding=’10‘ color=“ custom_font=’#ae8ca3′ av-medium-font-size-title=“ av-small-font-size-title=“ av-mini-font-size-title=“ av-medium-font-size=“ av-small-font-size=“ av-mini-font-size=“ av_uid=’av-kmlvzo8m‘ id=“ custom_class=“ admin_preview_bg=“][/av_heading]

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• Gebrauchsanweisungen
• Verpackung
• Etikettierung

Broschüren
• Betriebsanleitungen

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• Kurzanleitungen
• Stabilitätsstudien
• Technische Dossiers
• Produktkataloge
• Broschüren und Webinhalte

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• Einverständniserklärungen
• Protokolle für klinische Studien
• Softwarelokalisierung
für medizinische Geräte

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MDR is the new set of regulations governing the production and distribution of medical products in Europe. In this article, we tell you all about this new regulation.