Área Clientes | Colaboradores

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Los dispositivos médicos o productos sanitarios son todos aquellos instrumentos, equipos, implantes, materiales, etc. destinados al diagnóstico, prevención y tratamiento de enfermedades en seres humanos. También sirven a otros fines como por ejemplo el control de la concepción, etc. Dichos productos están sujetos a una estricta normativa, que puede variar en función del país en el que se comercialice el producto. Los dispositivos médicos se clasifican en los siguientes grupos:

A mayor grado de riesgo y mayor invasividad, más crítica se vuelve la adecuación de la traducción. No hay lugar a error. Todos los textos relacionados, como IFUs (instrucciones de uso), manuales de usuario, etiquetado, software, catálogos o folletos, han de ser fieles al original, exactos y precisos. Por eso, nuestros lingüistas son especialistas técnicos de solvencia demostrada pero, además, el proceso de revisión exhaustiva que exige la norma ISO 17100 garantiza una traducción libre de errores, incoherencias o inexactitudes.

Entre nuestros más importantes clientes de dispositivos médicos se cuentan fabricantes de: equipos de cirugía ocular, ecógrafos, desfibriladores externos, implantes para traumatología, prótesis para cirugía ortopédica, implantología dental, aparatología para cirugía estética, equipos de diagnóstico por la imagen, suturas y mallas quirúrgicas, equipos electro médicos, electroestimuladores para fisioterapia, productos para la salud bucal, sistemas de diagnóstico in vitro, dispositivos intra uterinos, equipos de monitorización no invasiva…

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[av_heading heading=’DOCUMENTOS PARA PRODUCTOS SANITARIOS’ tag=’h4′ link_apply=» link=’manually,http://’ link_target=» style=’blockquote modern-quote modern-centered’ size=» subheading_active=» subheading_size=’15’ margin=» padding=’10’ color=» custom_font=’#ae8ca3′ custom_class=» id=» admin_preview_bg=» av-desktop-hide=» av-medium-hide=» av-small-hide=» av-mini-hide=» 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-tlrt6′][/av_heading]

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• IFUs (Instructions for Use)
• Packaging
• Etiquetado
• Folletos
• Manuales de funcionamiento
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• Guías rápidas de uso
• Estudios de estabilidad
• Dosieres técnicos
• Catálogos de producto
• Folletos y contenidos web
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• Consentimientos informados
• Registros de protocolos de
investigación clínica
• Localización de software de
dispositivos médicos

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MDR es el nuevo conjunto de regulaciones que rige para la producción y distribución de productos sanitarios en Europa. Te contamos todo sobre este nuevo reglamento.

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.