Safe Medical Devices in all Languages

How to use an informational bridge to achieve conformity with MDR.

Safe Medical Devices in all Languages

If you've been following our blogs for some time, then you're already familiar with our informational bridge between technical editing and translation. Or, you can read my article about it now, because it hasn't lost any of its topicality or relevance. I'll wait a tick for you...

... Back again? Then you know that we at kothes aren't only active in the translation field, but can also draw on the specific knowledge associated with technical editing. In tricky situations, we simply ask our colleagues or pool our know-how.

The Medical Device Regulation (MDR) is currently both a hot topic and challenging situation for many manufacturers of medical devices: The MDR (2017/745) replaces the existing directives on medical devices MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directive). It's been valid since 25 May 2017 and should be applied from 26 May 2020 – according to the timetable established before the outbreak of the COVID-19 pandemic. Because of this, the European Commission has proposed the postponement of this date by one year, in order to avoid bureaucratic hurdles that may hinder the manufacture of important medical products. It can therefore be assumed that manufacturers of medical devices have initially won some time in implementing the directive. This should not, however, be an excuse to put off a subject that appears to be just a nuisance. Those who use the additional time will be well prepared for next year. But let's first consider the MDR's requirements.

Some of the changes, as compared with the old directives, concern technical documentation (refer also to our blog "MDR – New EU Medical Device Regulations"). Annex 2 of the MDR governs the requirements for the contents of specific documentation: In the categories of "Intended Use", "Physical Principle" and "Structure", for example, considerably more content is required than before. But also, requirements for labelling (e.g. brochures, catalogues and packaging) are specified. Furthermore, the documentation must be continuously updated.

Applying synergies across the "bridge"

Manufacturers of medical devices, who must adapt their documentation processes to be compliant with the MDR, will be confronted with considerable additional costs in the near future, due to the additional requirements for documentation. We can reduce these additional expenses with our "bridge", as we can (not only) take care of the translation, but also the technical editing and illustration, and maintain an overview of all areas (or more precisely, several) as part of our quality assurance processes.

This offers the following advantages, for example:

  • Optimised text creation through efficient terminology management, translation-friendly authoring and the use of powerful CMSs
  • Efficient question-answer management, thanks to the easy accessibility of Translation Project Managers
  • Continuous knowledge transfer between Technical Editorial and Translation departments
  • Systematic, partially-automated forwarding of essential information to Translators (e.g. terminology)
  • Time savings, via the online checking of translations within the various TM databases
  • Use of regular Translators with appropriate background knowledge of medical technologies
  • Certified translation management in accordance with DIN EN ISO 17100, with a focus on medical technologies
  • Continuous quality monitoring via the two-stage quality assurance of source texts and our LQA system for translations (LQA = Language Quality Assurance)

... So it's also possible to maintain high quality without the price and time variables becoming disproportionate. Because, "over this bridge", we use synergies that enable us to produce high-quality translations within a reasonable time and at a reasonable price.

Working economically in a quality-conscious industry

Exported medical technology should be (and remain) easy and clear to use for all users. I've lived in four different countries, and naturally, I'm very interested in ensuring that medical personnel can use their equipment safely, regardless of where I'm living or which language they speak there – even if an error message appears.

Yes, there are already certified translation processes and standards for good-quality translations. But translations for the medical technology sector should, in my opinion, be a step ahead! So how can we ensure that translations of operating manuals for medical devices are 100% bulletproof?

The careful pre-selection of Translators

In translation management, we take great care in carefully selecting our Translators, and we categorise them according to subject matter. This selection process, including test translations and training, is very complex and rigorous, but at the end of the day it's the solid foundation for our day-to-day work. With the support of modern translation memory systems, including the use of specialist terminology and Language Quality Assurance for each translation, a lot has already been done to ensure high translation quality, but in my world this isn't enough to translate, for example, the operating manual for a laser eye surgery device. So what else is possible?

Correct terminology plays a decisive role in a flawless translation (not only within the field of medical devices). We asked ourselves the question of how to bring together guidelines, technical editing and translation so that consistent wording is used across all documentation and translations. The magic word here is terminology management: We extract the terminology from guidelines (e.g. MDR), and make it available to Technical Editors via a terminology plug-in in the Content Management System. In this way, they're already using terminology that's consistent with guidelines when creating documentation. This terminology is simultaneously available to our Translators, via the central Terminology Management System, so that the terminology of the translations is consistent with both guidelines and the source text.

Pooling knowledge and using systems intelligently

We've made Smart Information our mission – and we live up to this mission in the field of translation. We provide our Translators with relevant information within their own smart space. Here, our regular Translators can access not only information on how to use the various translation systems, but also information on medical technologies that has been validated by our Quality Management department. For example, Translators can access the standards and guidelines in all available foreign languages. Our "MDR Taskforce" is also available at this point to answer specialists' questions.

As you can see, we invest both in the qualification of our staff and in smart systems that facilitate and accelerate the creation of texts and translations and, last but not least, contribute to the quality assurance of documentation for all project phases. This saves both time and money – and at the same time, you can rely on the high level of quality you're accustomed to.

Verena Döhler
Blog post Verena Döhler