“Thank you for the professionalism shown at all times and for your willingness to adapt to our needs. We'll keep in contact”.
Theresa Limbrunner, Morita
At AbroadLink, you will find a certified and specialised translation service with:
- Medical translators
- Premium services under ISO 9001, ISO 13485 and ISO 17100
- Competitive and adapted rates
- Timely delivery guarantee
Translation of medical devices
under the standard ISO 13485
Translation of instructions for use (IFUs), labels, brochures, catalogues, manuals or other documentation relating to a medical device is mandatory if you want to sell your products in the European Union, as currently laid down in the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
The European medical technology industry comprises around 34,000 companies. These companies have sales of around 140 billion euros with a 4% annual growth and employ around 800,000 people, according to data published by EUCOMED (European Medical Technology Association).
Given the importance and relevance of the sector, at AbroadLink Translations we have created a translation service specialising in healthcare products. With this goal in mind, we certified our translation services under the standard ISO 13485 for medical devices for the first time in January 2019. In accordance with this standard, at AbroadLink we guarantee that your translations with us are only performed by native translators specialised in the medical field.
In addition, we propose workflows adapted to the risk classification of each of your medical devices.
AbroadLink offers you years of experience in the translation of healthcare products and medical devices
AbroadLink brings to you a wealth of experience thanks to its translation services for global medical device manufacturers, importers and distributors: instructions for use (IFUs), websites, labels, clinical evaluations, declaration and certification of conformity, brochures, manuals, catalogues, software interfaces and other related documentation for a wide range of healthcare products and medical devices:
- Diagnostic and laboratory (IVDR): reactants, tests, enzymes, serology, bacteriology, parasitology, refrigerators, incubators.
- Hospital equipment and furniture: articulated beds, equipment trolleys, examination tables.
- Orthopaedics, prostheses and implants: bone substitute, osteosynthesis, silicone insoles, fasteners.
- Single-use products: stethoscopes, speculums, tuning forks, forceps, separators, scalpels, chisels, gouges, guidewires, catheters and medical torches.
- Electromedical and diagnostic imaging devices: electrocardiographs, scanners, audio meters, blood pressure gauges, tomography equipment, x-ray and radiotherapy equipment, incubators, defibrillators.
- Dental: implants, surgical instruments, centrifuges, biomaterials, dental equipment and instruments. For more information please visit our page regarding translation for the dental industry.
Specialised translators in medical and health technology
When you entrust your translation project to us, we can guarantee the professional quality of our translations thanks to the selection of translators with extensive experience in the translation of medical products and medical equipment. Many of our translators have specialised studies in the field of medicine, giving them a deeper knowledge and resulting in higher quality translations.
The implementation of the standard ISO 13485 at AbroadLink entails a provider selection procedure for highly specialised medical translators. Under our management system, translators are labelled as “ISO 13485” so that project managers can specifically assign projects of this nature to them. In order to qualify, they must have a professional profile with a specialisation in the medical field or have studies in medicine, nursing, veterinary medicine, osteopathy, biology, physiotherapy... We also consider translation and interpreting graduates with a master's degree in medical translation.
We translate from English
Thanks to our experience translating for international companies, we have a wide range of resources for the translation of English texts to other languages. When our clients from non-English speaking countries want to translate their documentation to other languages, we generally recommend that their translation projects are done from English.
While this strategy is not vital for languages such as German, French, Italian, Spanish or Portuguese, for a wide range of languages it is an essential approach: Chinese, Japanese, Korean, Russian, Arabic and other such languages. The level of professionalism, documentation resources and pool of highly specialised translators working from English allows us to offer more competitive translation rates and to deliver higher levels of quality.
We adapt to your translation needs
Not all companies are the same. In the medical equipment and health technology sector, 95% of the almost 34,000 companies making up the sector's European business structure are SMEs. Budgetary constraints, limited resources and the inability to achieve economies of scale mean that translation requirements differ between SMEs and large multinational corporations.
Another measure that allows us to offer our clients more competitive translation quotes as well as maintaining professional levels of quality is the implementation of a quality check on a sample of the translation. This process allows us to offer our clients a unique step in the translation process without carrying out a second revision, significantly reducing translation costs without renouncing a further quality control.
Translation under the ISO 17100 standard on translation services
When dealing with higher risk class products and when a quality assurance process is necessary due to the high sales volume of a product or for other specific reasons, AbroadLink offers ISO 17100 certified translation services.. This standard entails a quality assurance step consisting in the full revision of the translation by a second fully-qualified professional translator.
If you are interested in including translation as one of your procedures in your ISO 13485 implementation, you can read this article published in Multilingual and authored by us: "Translation procedure in ISO 13485 for medical devices"