A translation error in a set of instructions for use, for example, can have serious consequences. We are aware of this responsibility.
- Expertise: Our technical translators are experts in translating texts for medical products and medical devices. We work with translators from all over Europe, America and Asia.
- Accuracy: Sensitive documents are translated accurately into the target language, using the correct terminology, so that your product can be used safely and efficiently in other countries.
- Versatility: Our broad pool of translators allows us to rapidly handle all types of tasks on time, from instructions for use to promotional leaflets.
MDR: You are on the safe side with us.
Regulation (EU) 2017/745 on medical devices replaces two medical device directives: Directive 93/42/EEC on medical devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMD). Directive 98/79/EC on in vitro diagnostic medical devices (IVDs) has been replaced by the new regulation (EU) 2017/746 (in vitro diagnostic medical devices regulation – IVDR).
What requirements do the MDR and IVDR place on translation?
Neither the MDR nor the IVDR place specific requirements on the translation of technical documentation. However, paragraph 23.1(a) of the MDR states: “In particular, instructions for use shall be written in terms readily understood by the intended user […]”.
This means that instructions for use must be available in the user’s language in a way that is easy to understand. The requirements for translators and revisors of instructions for use are regulated by the quality standards for translation service providers, i.e. ISO 17100. Many notified bodies therefore require medical device manufacturers to have their translations produced by language service providers who specialise in medical technology and are ISO 17100 certified.
Do you need ISO 17100-compliant translations for your instructions for use?Then get in touch with us now.
We are ISO 17100 certified and offer translation of instructions for use for medical devices in all European languages!
We regularly translate the following kinds of material for well-known medical technology companies:
- Instructions for use, surgical manuals, guides
- Marketing material such as brochures, leaflets, press releases, websites
- All types of development documentation
- Software and apps
- All types of marketing authorisation documentation and studies
- All types of contracts
- Legal texts such as terms and conditions or data protection guidelines
- QM documents like quality management manuals, audit reports, process instructions and operating instructions
- Scientific articles, abstracts
- Sales texts such as offers, product catalogues
