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!

GUIDE ON MDR/IVDR TRANSLATION
AND LANGUAGE REQUIREMENTS
Fields marked with (*) are mandatory

Guide on MDR/IVDR translation
and language requirements

GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Regulatory compliance
Your main mission as PRRC is ensuring the safety and compliance of diagnostic devices. However, managing translations in different languages can become quite a challenge due to the complexity of the regulations.
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Specialised providers
In this free guide, we explain how to efficiently handle language requirements, from selecting specialised translation providers to validating texts, helping you to minimise errors and risks.
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Practical advice
Discover proven strategies and practical advice to optimise processes, save costs, and ensure that each document complies with the quality standards and regulatory requirements of each country.
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS

AbroadLink offers translation services
under the following quality standards

GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Download
ISO 13485
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Download
ISO 17100
GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS
Download
ISO 9001

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.

GUIDE ON MDR/IVDR TRANSLATION AND LANGUAGE REQUIREMENTS

We are members of GALA and TEAM-PRRC,
reaffirming our commitment to
industry best practices and regulatory compliance.

GALA
The Globalization and Localization Association (GALA)
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.
TEAM PRRC
TEAM-PRRC is the non-profit European Association
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.
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Comilla
I have been working with AbroadLink since 2014. They have always shown willingness and flexibility to meet the specific requirements of translating our instruction materials with great professionalism and attention to detail.
Leyre Vicente - Regulatory Affairs Manager
CerTest Biotec
Comilla
We are very satisfied. Fast and professional communication, very short delivery time and excellent service.
Kirsten Fedder
AKRUS GmbH & Co. KG
Comilla
We have used AbroadLink's translation services on several occasions during periods of high workload, always with satisfactory results. The assignments are handled reliably and professionally by a highly competent team of translators who strictly comply with the required specialised terminology and meet deadlines. Inquiries are answered promptly, and communication is always clear and friendly. Thank you very much!
Marcela Meyer
Gebr. Brasseler GmbH & Co. KG
>

Multilingual Solutions Enterprise

AbroadLink offers translation services under quality standards:
ISO 9001 ISO 17100 ISO 13485

Contact us

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+44 20 80 89 58 22 (UK)

www.abroadlink.com

C/Paseo de la Castellana 40, 8th Floor
28046, Madrid, Spain

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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

European Regional Development Fund
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