The Italian implementation decrees for Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will come into force on September 28. They will apply to all stakeholders (notified bodies, economic operators and healthcare operators).
Here’s a summary of what I have been doing in the last couple of months:
- I translated a set of Surgical Technique brochures into Italian
-In addition, I translated smaller documents, including some information leaflets about Comirnaty COVID-19 vaccine for 5-11 year-old-children
As an English to Italian Qualified ITI (Institute of Translation and Interpreting) member (MITI), I also obtained the ISO 17100:2015 Qualified status.
What does it mean? The ISO 17100:2015 Qualified status shows that I am working to international standards, and it demonstrates that I am a professional translator and that my skills and knowledge are maintained and updated.
As an English to Italian medical translator, I always strive for highest professional standards. And, being a qualified member of ITI (Institute of Translation and Interpreting), UK's only independent professional association of translators and interpreters, I follow a strict code of conduct. So my health and pharma customers can expect high quality Italian translations.
According to the new EU Regulation concerning Medical Devices (MDR) coming into force on May 26th 2021, it is up to distributors/importers to “ensure that the translation of information is accurate and up-to-date”. Therefore, you need trusted translators. Translating Health can help!
In our daily translation work at Translating Health, we often receive draft English texts, or documents that have not been finalised yet. So it is not unusual for us to spot errors and inaccuracies. As an integral part of our services, we regularly report these problems, with suggestions for improvement. Our clients appreciate this service very much.
At Translating Health, we felt the need to help fight coronavirus infodemia and to give our contribution as linguists. Therefore, we created an English-Italian COVID19 glossary to help people understand coronavirus-related concepts and terms. We hope it is a useful tool for translators and health providers.