Effects of the MDR on Translation and Documentation – An Interview

17.12.2018 - 14:09

Many questions are still open when it comes to the MDR. Anja Gebauer is in charge of International Sales at Transline Deutschland GmbH and recommends that affected companies take a look early on at their translation processes, since the scope and variety of translations is certain to increase.

Mrs. Gebauer, you are in charge of International Sales at Transline Deutschland GmbH and will be on hand at the T4M in May 2019 with your team. What three attributes would you use to describe Transline?

  • We are a reliable partner for translation and language consulting
  • We have over 32 years of well-founded expertise and process competence
  • 130 happy employees spanning the globe offer service with a passion

What are the special demands placed on medical technology companies with regard to translations in comparison to less-regulated markets?

In medical technology the throughput time, resulting from time-to-markets, product lifecycles, and stiff competition, is just as important as in other industries. However, medical technology companies experience particular pressure when it comes to language and translation quality. After all, an incorrect translation could have fatal results.

The number of different language versions is also a decisive factor. One reason for this is that user information must always be available in the official national language before a product may be launched on the market. This is an organizational challenge for many companies. Finding the right translator requires intuition and knowledge, as well as access to a large network of language providers.

What are the special challenges facing the medical technology industry? Do these challenges have an influence on your translation processes or suppliers?

Unfortunately, the EU Medical Devices Regulation (MDR) presents many of our customers with a lot of insecurity and uncertainty. Translation is only a small part of this new regulation, but it can have a huge effect due to strict safety requirements. Whereas 50 pages of documentation would have been sufficient in the past, now over 150 pages are required. This is reflected in the time required and budget. We therefore recommend that you deal with this topic early on and check how a clever process can help you here. Many of our customers are already well positioned in this respect and only have to make slight adjustments to comply with the requirements in the MDR. Other companies will be impacted more by this regulation.

Texts from various company divisions, such as documentation, development, and marketing, will have to be translated. How do you know who is the best person for the respective project?

Transline is certified in line with ISO 17100 and ISO 9001. Our translator selection process has always been extremely strict: we go through all of the relevant quality criteria during onboarding and have the translator or agency do complex test translations. Here, we check whether the applicant fulfils our standards in the specified specialist field and which type of text is suitable for the translator. Once the first projects are underway, the new supplier is subjected to strict tests until they have proven themselves as a reliable partner and established themselves in our assessment system.

However, you also have to go beyond this and respond individually to the requirements of the respective customer, remain in close contact and find out what is important to them. Style requirements, specialised terminology and much more also play an essential role.

For example, in a purely technical translation the specialist translator must write in a structured manner, be proficient in the technical and company terminology, and is not allowed to use any flowery language. On the other hand, this results in fast project processing thanks to standardised and extensively automated processes.

You decided to exhibit at the T4M. Why? How can you tell if this will be worthwhile for you?

The medical technology sector is continually growing at Transline and we already have several well-known customers who rely on our expertise. We certainly need to be present at such a trade fair. The location is an added advantage: our headquarters in Reutlingen are just around the corner from the Messe Stuttgart. In addition, the MDR is one of the main topics at the T4M and that suits us well, since we have been dealing with this for some time. The trade fair is thus an opportunity for use to show what we can do – and a good opportunity for visitors to get to know Transline as a full-service provider of specialised translations and language consulting. We can only profit from the opportunity to acquire new impulses by directly talking with employees from interesting companies and sharing our expertise.

We heard that you already took part as an exhibitor at the annual tekom annual conference here on the fair grounds. Was the EU MDR discussed during this conference? How was the mood at the conference?

There were several lectures on the MDR, but not in relation to translation. It is probably still too early. Right now, there is a task force in Germany to implement the MDR. All of the relevant authorities and associations are working together in this team. However, many questions are still open and the work is ongoing.

In general, technical writers from the medical technology industry did not feel well represented at the tekom conference, according to feedback received from our customers. Mechanical engineering is very dominant at this conference, pushing medical technology to the side.

Can you describe in one sentence what visitors can look forward to at the Transline stand at the T4M?

Professional advice regarding the translation process in the context of the MDR, as well as a friendly and committed team that is looking forward to interesting discussions.

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