The medical field is an area where new procedures, new equipment, or new research is the norm. When manufacturers of medical equipment need to publish information, IFUs (Information for Use), or product documentation in foreign countries, it is imperative that the documentation is accurate and correctly translated into the target languages. Selling products to Europe is no exception. Article 4(4) of the Medical Device Directive allows member states to “require the information, which must be made available to the user and the patient in accordance with Annex 1, Point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or patient use.” The basic requirement is that the user should be provided with the required information to understand how to use your device. Medical document translation is a vital component in the development, sale, and distribution of your instructions and product literature in foreign countries .
At Apex, our medical document translation is performed by professional medical translators who are native speakers in the target language and are fluent in the source language. This means that you don’t have to use a distributor to provide the translation service, or worse yet – use an online translation application to translate your medical documents. Instead you have educated, bi- or multilingual medical professionals working to ensure that your documents are translated perfectly. Medical translation services are important and must be accurate not only because they are required; consider this investment as an opportunity to promote the proper use of your products and demonstrate your dedication to the European market, while at the same time limiting your liability exposure.
