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Scientific Translations
The biomedical industry is one of the primary drivers of the economic environment in which our translation business has evolved.
Thanks to our work with several leading companies in the field, interlanguage can boast a legacy of experience in the translation of medical, biomedical and pharmaceutical literature, and we guarantee strict compliance with the technical terminology officially sanctioned within the EU.
Medical devices directive 93/42/EEC
For example, in compliance with the “medical devices directive” 93/42/EEC, all devices sold in other countries must be accompanied by documentation translated into the official languages of the destination markets: user and maintenance handbooks, documents for end users (including safety labels on packing, software, hardware and firmware) and documents identify the manufacturer. This information is necessary to ensure safe use of the device and is addressed to users with a wide range of different skills and training levels. In this context it essential to distinguish between literature for healthcare professionals and literature for patients. Professional users must comply with specific rules for each country. For example, in some EU countries English is accepted on labels. However, in non-EU countries all documentation must be provided in the local language.
The application of the directive therefore obliges manufacturers to implement procedures within their Quality System that assure the maximum accuracy in the translation of commercial literature, labels, and, in particular, directions for use: in this latter case, mistranslations or misleading translations could impact negatively on safety and the attainment of the performance levels stated in the documents.
Come lavora interlanguage
That’s why it is essential to entrust the job to a competent partner. interlanguage takes the greatest care in selecting translators who are specialised in the sector and who write only in their native language. The translated text is subjected to a checking procedure, performed by interlanguage’s revisers and project managers, who also have experience in the same sectors. Our personnel regularly attend refresher courses for scientific translations and they are in possession of advanced competences in the realm of terminology management and computer assisted translation. This allows us to optimise turnaround times and also ensure direct contact with the customer to resolve any queries that may arise during the translation process. Validation of the translation is an essential stage of the process. interlanguage can forward the translation to a client-appointed reviewer (an expert in the local language, a dealer on the export market, or a product promoter). This procedure ensures the currency and adequacy of medical / technical terminology in compliance with the regulations in force in the destination country and in consideration of the use for which the device is destined in hospitals and healthcare facilities.
Tipologie di testo
interlanguage supplies translations of all types of medical-scientific literature, including:
- Technical conditions
- Medical device handbooks
- Instructions for use (IFU)
- House newsletters
- Technical datasheets
- Declarations of conformity
- Software
- Labels
- Drug Master Files
- Product information sheets
- Clinical studies
- Research protocols
- Information packages for patients
- Informed consent documents
- Product characteristic summaries (SPC)
- Posters and Abstracts
- Articles for scientific journals
- Medical reports
- Patient information
- Medical Q&As
- Translation certification
- Judicial authentication
- Medical Approval
Our translation service is certified in compliance with European standard UNI EN 10538:2006. For more information and quotes, contact
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