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English to Italian English to Spanish Italian to English Spanish to English Italian to Spanish
English to Italian: MD Quality System Certificate - Certificato del Sistema Qualità DM General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Quality System Certificate
This is to certify that the quality system of
fulfils the requirements in
DS/EN ISO 13485:2003 AC:2007
The scope of the certificate is:
Design, development and manufacture of implantable hydrogel products.
Design, development and manufacture of urethral bulking procedure packs.
Design, development and manufacture of guidance devices intended to be used with implantable hydrogel products.
The certificate is valid provided that the quality system continues to conform to the above-mentioned scope and provided that the
company does not introduce substantial changes to the quality system without the approval of DS Certificering A/S.
The quality system certificate is issued pursuant to the DS Certificering A/S rules for the certification of quality systems for medical
Translation - Italian Certificato del Sistema Qualità
Con la presente si certifica che il sistema qualità di:
soddisfa i requisiti della norma
DS/EN ISO 13485:2003 AC:2007
Il campo di applicazione del certificato è:
Progettazione, sviluppo e fabbricazione di prodotti impiantabili in idrogel.
Progettazione, sviluppo e fabbricazione di kit per bulking uretrale.
Progettazione, sviluppo e fabbricazione di dispositivi guida previsti per l’uso
con prodotti impiantabili in idrogel.
Il presente certificato è valido purché il sistema qualità continui a rispondere al campo di applicazione di cui sopra e purché l’azienda non introduca cambiamenti sostanziali nel sistema qualità senza l’approvazione di DS Certificering A/S.
Il certificato del sistema qualità viene rilasciato ai sensi delle regole di DS Certificering A/S relative alla certificazione dei sistemi qualità per i dispositivi medici.
English to Spanish: Bonds - Bonos General field: Bus/Financial Detailed field: Finance (general)
Source text - English Wherever by the laws of the United States or regulations made pursuant thereto, any person is required to furnish any recognizance, stipulation, bond, guranty, or undertaking, hereinafter called "penal bond", with surety or sureties, such person may, in lieu of such surety or sureties, deposit as security with the official having authority to approve such penal bond, United States Liberty Bonds or other bonds or notes of the United States in a sum equal at their par value to the amount of such penal bond required to be furnished, together with an agreement authorizing such official to collect or sell such bonds or notes so deposited in case of any default in the performance of any of the conditions or stipulations of such penal bond.
Translation - Spanish Dondequiera que en virtud de las leyes de los Estados Unidos o de las disposiciones legales dictadas en conformidad con las mismas, cualquier persona deba suministrar cualquier fianza, estipulación, bono, garantía o prenda, de aquí en adelante llamado "bono penal", con fianza o fianzas, dicha persona podrá, en lugar de dicha fianza o fianzas, depositar como garantía con el funcionario autorizado para aprobar dicho bono penal, United States Liberty Bonds (Bonos de la Libertad de los Estados Unidos) u otros bonos o instrumentos de adeudo de los Estados Unidos, por una suma igual, a su valor nominal, al monto de dicho bono penal que se requiere ser suministrado, adjuntando una autorización para que dicho funcionario cobre o venda los bonos o instrumentos de adeudo depositados de esta forma en caso de incumplimiento de cualesquiera de las condiciones o términos del citado bono penal.
Bachelor's degree - Universidad de la República del Uruguay
Years of translation experience: 21. Registered at ProZ.com: Jan 2000. Became a member: Jan 2002.
English to Spanish (Universidad de la República (Facultad de Derecho), verified) French to Spanish (Alliance Française, verified) English to Italian (AITI EN>IT) English to Spanish (AITI EN>ES) Spanish to English (Universidad de la República (Facultad de Derecho))
I am a freelance medical translator, specializing in medical devices, bariatrics, and clinical trials. I have a "regulatory way of thinking" acquired by working as an RA&QA Specialist at Johnson & Johnson Medical Italy for 10 years. I also enjoy technical translation, and I have experience in a variety of fields such as HVAC, refrigeration, electronic controls, foodservice equipment, mechanics, business, and finance. I am accurate and intellectually curious, and that's why I usually carry out terminology searches with the help of corpora, prior to starting any assignment.
I offer the following services:
• medical translation:
clinical trial documentation, Informed Consent Forms, Clinical Trial Agreements, Instructions for Use, Directions for Use, regulatory documentation of Medical Devices and drugs, CE certificates, ISO certificates, Design Examination certificates, user's manuals of electromedical devices, marketing materials, promotional materials, brochures, Summary of Product Characteristics,
• technical translation:
user's manuals, technical data sheets, material safety data sheets, marketing materials, sales materials, quality manuals, quality procedures.
•Editing of scientific manuscripts for publication
•MT post-editing: SDL Certified
• literary translation
nonfiction, stories, manuals, etc.
• specialized consecutive interpretation for Medical Device and Pharmaceutical Companies
presentations, meetings, negotiations, etc.
For technical and medical translations, I work in the following language combinations:
• Italian into Spanish and Spanish into Italian,
• English into Italian and Italian into English,
• English into Spanish and Spanish into English,
• French into Italian,
• French into Spanish.
For literary translations, I work only in the following language combinations:
• English and Italian into Spanish and
• English and Spanish into Italian.
I specialize in the following fields:
• clinical trials (CTAs, Informed Consent, Amendments, etc.),
• medical devices,
• quality systems,
• healthcare regulatory affairs,
• electronic controls,
• business & banking.
To translate, I use these CAT Tools:
• SDL Trados Studio 2014
• DéjàVu X2 Professional
• MemoQ 2014 R2
Born in Uruguay in 1966, I hold a degree in English<>Spanish Translation obtained from the University of Uruguay in 1989.
The following year I moved to Italy.
After holding several jobs as secretary, executive secretary, and import/export associate, in 1997 I finally achieved my long-cherished dream to live on my profession. In fact, I opened a Translation Agency which I successfully managed until 2003. During this period, I entered the technical translation world by translating user’s manuals as well as technical and commercial documentation for companies in several industries (refrigeration, electronic controls, foodservice equipment, eyewear).
From 2003 to 2013 I worked for a Johnson & Johnson Company near Rome and was mainly involved with quality systems and medical devices.
Then, in May 2013 both work and personal reasons induced me to return to the freelance translating life, specializing in medical translation. In addition to resuming my technical translation activity, I have now decided to personally contribute to draw the cultures of Uruguay and Italy closer by entering the literary translation world in two language pairs: Italian into Spanish and Spanish into Italian. I am currently translating "The Big Book on the Lap-Band" into Italian.