The EU Regulations 2017/745 on medical devices and 2017/746 on in-vitro MD from 2017, known as MDR and IVDR, are having deep consequences over the MedTech industry. What are the language requirements established by them? How can translation professionals be prepared to best serve MD linguistic needs? What are the profiles searched by specialized translation companies? What are the related standards? What type of documents need to be translated?
Das lernen Sie
Understanding of MDR/IVDR language requirements
Keys to offer a translation service addressing the needs of MedTech companies
Typology of documents being translated under MDR/IVDR
References to valuable linguistic resources
Knowledge at language technology, tools and linguistic competences for translating. The target audience will be mainly translation professionals. Some knowledge of European legislation machine and the MDR or IVDR will definitely help, but it is not necessary.
Josh Gambín holds a five-year degree in Biology, majoring Biochemistry, and a four-year degree in Translation and Interpreting. He has worked as an in-house and freelance translator, Project Manager, Quality Manager and DTP operator. He is a founding member of AbroadLink Translations and currently is the Sales and Marketing Director.
Sonja holds a degree in translation and interpreting from the Autonomous University of Barcelona and a Master's degree in Interpreting from the University of Granada (Spain). She speaks 5 languages, 3 of them at a native level: German, Spanish and Catalonian. She is currently a senior project manager at AbroadLink Translations.