Medical Device Translation
Recent press reports have highlighted the potential for and consequences of error in medical device translation. Setting aside the extreme possibility of loss of life and limb, and the distress caused to patients, remedial surgery for example to fix prosthesis implantations that have failed because of mistranslated labelling or operator instructions can be extremely expensive, especially when associated with legal costs.
Furthermore, medical device translation is addressed by various pieces of European legislation covering the need for information relating to medical devices to be translated into one or more languages of the European Union. These are summarised in a European Commission guidance document, which states that: “As part of the quality system or of the documents defining the manufacturing process, the manufacturer should have procedures for ensuring accurate translation of e.g. labelling, instructions for use and product claims in marketing material. These are especially important for user instructions where the safety and claimed performance of the device may be compromised through inadequate translation.” Member States are allowed to stipulate in their implementing legislation that the information needed to use a device (labelling and instructions) is in their official language. If the device is a device for self-testing, the instructions for use and label must include a translation into the official language of any member state of the community in which the device reaches a final user.
Specialist medical device translation requires thorough subject knowledge. Zebra works with many high-quality specialist translators from across the world, with an extensive knowledge of the medical industry, often as a result of a previous career in the profession. Our translators include former or currently practising surgeons, general practitioners, nurses and academics who are competent in medical device translation.
We also believe that having quality translators living in the country of their target language gives us an added competitive edge, particularly in medical device translation. You can be safe in the knowledge that whatever language you require your text to be translated into, the professional that undertakes it will be a native to that country, and almost always based in the country as well. This ensures that cultural factors are also taken into account, to guarantee a high quality text.
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