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English to Spanish: Cochlear implants General field: Medical Detailed field: Medical (general)
Source text - English The purpose of this report is to evaluate available clinical evidence to support claims on the safety and efficacy characteristics of the XXXXXXXX cochlear implant. The XXXX builds upon components identical to those used in the approved XXXXXXX device (the principal predicate device), except for the intracochlear electrode array (XXXX) which is new and not available in any approved cochlear implant.
Both the XXXXX and XXXXX are intended for restoration of hearing sensation by electrical stimulation of the auditory nerve in patients with moderate to profound sensorineural hearing loss. Specifically, the report aims to confirm that the XXXXXX complies with the Essential Requirements as listed in ‘AIMD Directive 90/385/EEC Annex 1’ relating to safety and performance when used as intended.
Translation - Spanish El objetivo de este informe es evaluar la evidencia clínica disponible para respaldar las afirmaciones sobre las características de seguridad y eficacia del implante coclear XXXXXX. El XXXXX tiene los mismos componentes que los utilizados en el dispositivo aprobado XXXXX (el dispositivo previamente homologado), excepto por la disposición de la cadena de electrodos intracoclear (XXXX), que es nueva y no está disponible en ningún implante coclear aprobado.
Tanto el XXXXX como el XXXX están diseñados para restaurar la sensación de audición por medio de la estimulación eléctrica del nervio auditivo en pacientes con pérdida auditiva neurosensorial de moderada a profunda. Específicamente, el objetivo del informe es confirmar que el XXXX cumple con los Requisitos Esenciales, según lo indicado en la “Directiva AIMD 90/385/EEC, Anexo 1”, en relación con la seguridad y el desempeño cuando se usa según lo previsto.
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Bachelor's degree - Universidad Nacional de Rosario
Experience
Years of experience: 17. Registered at ProZ.com: Aug 2018.
I am form Argentina and I am a qualified, reliable and
detail-oriented translator with over 10 years of
experience translating, editing and proofreading files in
Spanish for a number of translation agencies and small
personal clients.
I guarantee the highest quality and punctuality in all my assignments. I am
able to handle large volume projects as well as small assignments. My areas of
expertise include Healthcare, Medical Sciences, Clinical Trials, Patents,
Technical and User Manuals, Marketing, amongst others.
Keywords: Translator, editor, English, Spanish, experience, reliability, high-quality, attention to details, punctuality, CAT tools. See more.Translator, editor, English, Spanish, experience, reliability, high-quality, attention to details, punctuality, CAT tools, medical, marketing, tourism, technical. See less.
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