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[av_rotator_item title=’PRODUCTOS SANITARIOS’ link=» linktarget=» custom_title=» av_uid=’av-lqp82′]
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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:
- Clase I: incluye los dispositivos que presentan un grado muy bajo de riesgo.
- Clase II: incluye los dispositivos que presentan un grado de riesgo moderado.
- Clase III: incluye los dispositivos que presentan un elevado potencial de riesgo.
- Clase IV: incluye los dispositivos considerados los más críticos en materia de riesgos.
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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