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Sample translations submitted: 1
English to Spanish: Fragmento de Estudio Laringoscopios
Source text - English Overview
This document outlines the technical information of the device and demonstrates its compliance with the essential requirements of the directives for safety and performance which apply to it. Methods of compliance include completion of essential requirements checklist, verification and validation reports and testing.
The device is manufactured in a controlled process and undergone rigorous quality control to consistently maintain product quality.
Device Family
Laryngoscope Blades
Intended Use
These types of laryngoscope blades are single-use device intended to illuminate and examine a patient’s oral cavity and upper airway and aid placement of a tracheal tube during intubation.
Applied Directives
Medical Device Directive 93/42/EEC (as amended)
Translation - Spanish Resumen
Este documento describe la información técnica del dispositivo y demuestra su cumplimiento con los requerimientos esenciales de las directrices de seguridad y manejo que le son aplicados. Los métodos de cumplimiento incluyen la conclusión de la lista de requerimientos, verificación y reportes de validación y prueba.
El dispositivo es fabricado en un proceso controlado y bajo rigurosos controles de calidad para mantener consistentemente la calidad del mismo.
Familia del dispositivo
Cuchillas para Laringoscopia.
Uso previsto
Este tipo de cuchillas son dispositivos de un sólo uso, destinados a iluminar y examinar la cavidad oral y vías respiratorias superiores del paciente, así como un auxiliar en la colocación de un tubo traqueal durante una intubación.
Normativas Aplicadas
Normativa de Dispositivos Médicos 93/42/EEC (enmendada)
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Experience
Years of experience: 7. Registered at ProZ.com: Aug 2020.
Chemist who has experience on translation of medical documents such a Clinical studies. Also, I am well educated and experienced on the translation of Drug Master Files for Medicines, Medical Devices and Vaccines.
Keywords: Spanish, English, Medical devices, vaccines, vacunas, dispositivos médicos, medicamentos, drug product, drug substance.