TRANSLATIONS FOR MEDICAL DEVICES

Translations for medical devices

What is the role of translation in the field of medical devices?

In recent years, new European directives have brought fundamental changes to the medical devices sector, including the recent MDR 2017/745: which includes the extension of the field of application, the clinical evidence required for all devices, the new figure of the person responsible for regulatory compliance, the Unique Device Identification system, the establishment of the European database on medical devices (Eudamed), more rigorous post-marketing surveillance and closer attention to technical characteristics.

With increasingly stringent legal requirements on the one hand and continuous development and constant technological evolution of medical devices and IVDs on the other, there is the need for documentation that not only meets legal requirements but that is also user friendly and easy to understand.

This is because medical devices and IVDs are definitely essential for doctors and pharmacologists, but also play a major role in promoting patients’ and carers’ autonomy.

With greater interaction between technology – including medical technology – and people, the translation of medical device documentation is increasingly becoming not only a legal obligation but also an ethical duty and a responsibility for those commissioning such translations and those executing them.

Given the growing use of medical devices by non-specialists, the translated information material accompanying them must be accurate, precise, clear and easily understandable.

 

The importance of continuing professional development

Why is continuing professional development so important for translators specialising in the field of medical devices?

Continuing professional development is essential for our profession as it allows us to understand how documentation evolves in terms of the terminology, lexicon and register of documents associated with medical devices (posters, marketing brochures, instructions for use, warranties, etc.). Keeping up to date is a must when providing a quality service. This can only be done through continuing professional development and participation in workshops, seminars and conferences.

 

The importance of ONLY translating what you know

In-depth knowledge of legislation, regulations and provisions, as well as manufacturer’s indications and instructions, are essential for translators as they must transfer how a device operates from one language to another clearly, correctly and intelligibly in order to reduce to a minimum any risks arising from the use of these devices.

Being informed means finding reference material, taking a close look at devices, and attending conferences and trade fairs where these devices are presented and used. This is why we attend the annual Mediterranean Health Care Forum and other trade fairs, including MedTec, where we can get to know and physically touch the devices we translate.

 

Anything else?

And, last but not least, we keep a close working relationship with our clients, ensuring a fruitful exchange of expertise and experience, and efficient problem solving.

This is why we don’t consider ourselves simply a service provider but rather a partner – someone to help you achieve your most important objectives!

PHARMATRAD TRADUZIONI MEDICHE, FARMACEUTICHE, SCIENTIFICHE. Taduttore medico scientifico: ricerca clinica, malattie rare, studi clinici, italiano, inglese

Clinical research

In a field like medicine and clinical trials, one individual word makes all the difference. This is why we carry out our work making constant and careful reference to official resources such as MedDRA, the EDQM Standard Terms, and the WHO’s International Classification of Diseases (ICD), as well as official documentation from the EMA, Italian Medicines Agency (AIFA) and other institutions.

PHARMATRAD TRADUZIONI MEDICHE, FARMACEUTICHE, SCIENTIFICHE. Taduttore medico scientifico: ricerca clinica, malattie rare, studi clinici, italiano, inglese

Rare diseases

Since the field of rare diseases is a relatively new topic, there are infinite possibilities for development; its lexicon and conceptual categories have yet to become widely accepted. The translator’s role therefore involves following closely developments in the field, both in terms of content and terminology, which will certainly take place over the coming years.

PHARMATRAD TRADUZIONI MEDICHE, FARMACEUTICHE, SCIENTIFICHE. Taduttore medico scientifico: ricerca clinica, malattie rare, studi clinici, italiano, inglese

Medical devices

In-depth knowledge of legislation, regulations and provisions, as well as manufacturer’s indications and  instructions, are essential for translators. They must transfer how a  device operates from one language to another clearly, correctly and intelligibly in order to reduce to a minimum any risks arising from the use of these devices.

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