The ultimate guide
to meeting
language requirements
Discover how to ensure professional translations
and comply with European regulations (MDR/IVDR)
without risks or delays.
Which documents are mandatory to translate and into which languages?
Which translations are accepted by Notified Bodies?
Download our guide to discover this and much more!
AND LANGUAGE REQUIREMENTS
Guide on MDR/IVDR translation
and language requirements
AbroadLink offers translation services
under the following quality standards
AbroadLink and ISO 13485 certification
Benefit from our experience in medical device translation.
We guarantee high-quality standards thanks to a
strict selection process of highly specialised medical translators.
Ensure the use of official MDR/IVDR terminology and obtain a translation certificate
for each project.
We are members of GALA and TEAM-PRRC,
reaffirming our commitment to
industry best practices and regulatory compliance.
is a non-profit organisation.
GALA provides services and support to the
global language services and technologies
industry, which includes translation, interpreting,
localisation, and the technologies that support these
activities.
dedicated to the new profession of "Person
responsible for regulatory compliance" (PRRC),
which originated in Article 15 of Regulation (EU)
2017/745 (MDR) and in Article 15 of Regulation (EU) 2017/746 (IVDR)
of the European Parliament
and of the Medical Device Council.
Multilingual Solutions Enterprise
AbroadLink offers translation services under quality standards:
Contact us
C/Paseo de la Castellana 40, 8th Floor
28046, Madrid, Spain
AbroadLink Translations, S.L. has been a beneficiary of the European Regional Development Fund whose objectives is to improve the sustainable growth and competitiveness of SMEs and thanks to which it has launched an Action Plan with the aim of improving its competitiveness in foreign markets through digital transformation, online promotion and e-commerce during 2024. To this end, it has been supported by the XPANDE DIGITAL Programme of the Granada Chamber of Commerce. #EuropaSeSiente
AbroadLink Translations, S.L. has been a beneficiary of the European Regional Development Fund whose objectives is to improve the sustainable growth and competitiveness of SMEs and thanks to which it has launched an Action Plan with the aim of improving its competitiveness in foreign markets through digital transformation, online promotion and e-commerce during 2024. To this end, it has been supported by the XPANDE Programme of the Granada Chamber of Commerce. #EuropaSeSiente
Thank you for your interest in our guide!
You can find our guide in the downloads folder on your computer.
You will also receive an email with the download link.