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Medical devices, a new frontier for scientific translations

Scientific translations of materials regarding medical devices are the subject of increased activities worldwide: this is mainly due to the spreading of the COVID-19 pandemic, and to the arrival on the market of new devices for the diagnosis and control of the infection.

Actually, the products that reached our market in huge quantities include not only surgical masks and latex gloves, but also kits for swabs and serological tests, infrared thermometers, and other thermal scanners to measure body temperature. Regulatory affairs operators taking care of the registration of medical devices have practically worked on anything else in this period; and these registrations also included the submission of translated materials, especially manuals and instructions for use (IFUs), intended for health professionals involved in the monitoring and prevention.

It should be said that the demand for translations of scientific documentation accompanying medical devices has, in general, highly increased in the last few years, often surpassing the demand for pharmaceutical translations for the marketing of medicinal products for human use.

This documentation can regard not only simple kits for laboratory testing, thermometers, manometers, and other instruments frequently used in healthcare, but also more complex equipment for diagnostic use, perhaps including a software, surgical tools, and even particularly sensitive devices such as implantable devices, intended to interact with our body, also containing pharmacological substances.

The translation of the material concerning these devices, including implantable devices and in vitro diagnostics, should therefore be performed with extreme care and considerable competence in the technological and medical field. Errors and inaccuracies in the translation can compromise the use, and therefore the functioning, of high-tech devices, with important consequences on public health. For this reason, translating these materials often requires a thorough training, continuous updating, and quality certifications.

For companies lacking of departments dedicated to the drafting and translation of these materials inside their organisation, specialised translation agencies are now available just for the translation of this kind of documents. Translation is entrusted to qualified and specialised translators, having the expertise required to ensure that the outcome of the translated scientific, medical and pharmacological texts is precise and functional.

Many of these agencies can also count on the work of revision by professionals of the health sector, thus ensuring the accuracy and quality of the translation itself. The specialisation of these agencies goes so far as to have an actual editorial staff including translators as well as editors specialised in health and science. The also include the so called “medical writers”, who can draft regulatory texts or research and development documentation.

The cooperation of these specialists ensures text quality. Moreover, the release of quality certifications, now also available for translations, and the use of supporting high-tech tools complete the picture: outsourcing this active is a very common practice, discharging pharmaceutical companies from the responsibility to ensure a burdensome service in terms of time and resources.

Written by: Maria Pia Felici