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Standards and directives:                                                                                                                                
UNE EN 15038:2006

In 2006, the European Committee for Standardization (CEN) published the UNE-EN 15038 standard, which defines the requirements for the provision of translation services.

Although compliance is not compulsory, the standard is widely accepted and increasingly used. The European Union has begun to include the standard as a point of reference in its specifications for calls for tenders issued for translation services.

The UNE EN 15038 standard offers clients, in particular companies who are not familiar with the translation industry but need these services, a benchmark and minimum level of assurance regarding the quality of the service contracted. The main objectives of this standard include terminology standardization, definition of basic requirements for provision of the service, and creation of a framework in which clients and translation service providers can interact.

"In March 2012 FiTranslation was certified as compliant with the requirements of the UNE EN 15038 standard a mere year after the firm was founded. The business project has allowed FiTranslation to grow with a demanding quality commitment consistent with the requirements of this standard."

Experience in regulatory requirements:

From the very start, we have been involved in helping our clients identify their requirements, a task that is often confusing and labor-intensive for sectors such as health and pharmaceuticals with regard to translation, in-country review and other needs.

If you require advice regarding the translation of materials for your industry, such as CE mark certificates, label translation and transcription in many languages, in-country review management for the target countries, marketing campaign adaptation of pharmaceutical products, FiTranslation can offer any service you need in which our know-how, always cutting-edge, can help you enter other markets.

Our familiarity with the following aspects can give you some guideline:

Medical device materials
To sell products in Europe, all non-European manufacturers must comply with the European language requirements of the country to which they wish to export their products. The legal requirements for medical devices have made translation services an even more important issue. For example, the European Directives on in vitro diagnostic medical devices require product documentation to be translated into the language of the country where they will be marketed.

In Europe the regulations for medical devices basically stem from three European directives:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
To certify compliance, there are several documents of variable importance and availability depending on the medical device:

The CE mark, a symbol that must appear on the label, instruction leaflets, or manufacturing plaques for equipment, is itself an express statement that the product meets all essential requirements and applicable procedures to evaluate conformity. Therefore, all products with the CE mark can be considered approved. The CE mark is accompanied by four digits that correspond to the notified body that was involved in evaluating the products.

Certification documents:

CE declaration of conformity:

Medical device manufacturers must issue a CE Declaration of Conformity to certify that their products comply with all applicable mandatory requirements. The CE Declaration of Conformity is a document written in the manufacturer’s language and kept in its possession, so it can be shown to authorities for control purposes or to respond to any issues, disputes or claims that might arise. The translation of the CE Declaration can be requested for a comprehensible language or the target language of the country where the product will be distributed, when necessary for the purposes of certifying product conformity.
The CE Declaration of Conformity is a document written in the manufacturer’s language and kept in its possession, so it can be shown to authorities for control purposes or to respond to any issues, disputes or claims that might arise.
The translation of the CE Declaration can be requested for a comprehensible language or the target language of the country where the product will be distributed, when necessary for the purposes of certifying product conformity.

Notified body certifications
Notified bodies issue the certificates corresponding to the procedures followed to evaluate the products. These certificates must always list one of the annexes of the respective directive (Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/CE).
The certificates attest to the conformity of the products they cover; these products are usually specified in annexes and assigned to product types or families rather than tradenames.

Other standards:
ISO 9001:2008 which establishes the requirements for a Quality Management System
ASTM F2575-06 Standard Guide for Quality Assurance in Translation
Feel free to ask other standards

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