AbroadLink Translations renews ISO 9001, ISO 17100 & ISO 13485
At AbroadLink Translations, we are delighted to announce the successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications. This achievement demonstrates our unwavering commitment to quality, accuracy, and compliance in Life Sciences translations, particularly in the highly regulated field of medical devices in Europe.
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A Strong Commitment to Quality and Compliance
For companies operating in the Life Sciences and medical device sectors, precision in translation is not optional, it is essential. By renewing our three ISO certifications, we guarantee that our processes meet the highest international standards, giving our clients confidence in the safety, accuracy, and compliance of their multilingual documentation.
Our certifications include:
- ISO 9001 – Quality Management Systems: Ensures structured processes, continuous improvement, and customer satisfaction.
- ISO 17100 – Translation Services: The most demanding international standard for translation, requiring strict processes, qualified linguists, and a mandatory second review of every translation.
- ISO 13485 – Medical Devices Quality Management: Originally designed for medical device manufacturers, this certification guarantees that our translation processes meet the same stringent requirements applied to medical device companies under EU MDR (2017/745) and IVDR (2017/746).
Why ISO Certifications Matter in Medical Device Translations
In regulated industries such as medical devices, pharmaceuticals, and biotechnology, even a minor translation error can have serious implications for patient safety and regulatory compliance. That is why ISO-certified processes are vital.
- ISO 9001 ensures robust management and consistent quality.
- ISO 17100 guarantees every translation undergoes bilingual revision by a second professional, eliminating omissions or errors.
- ISO 13485 highlights our unique role as one of the few language service providers aligning with the same quality standards required of medical device manufacturers.
With these certifications, AbroadLink Translations offers Life Sciences companies across Europe and beyond the peace of mind that their critical documents such as clinical evaluations, IFUs, labeling, and regulatory submissions are handled with the highest precision.
A Trusted Translation Partner for the Life Sciences Industry
AbroadLink has years of expertise supporting medical device manufacturers, pharmaceutical companies, CROs, and research organizations. Our specialized team, combined with certified processes, helps clients:
- Stay compliant with EU MDR/IVDR requirements and global regulatory frameworks.
- Ensure linguistic accuracy and clarity across multilingual markets.
- Expand internationally with translations adapted to both scientific and cultural contexts.
By combining linguistic excellence with regulatory expertise, we position ourselves as a trusted partner for companies that need specialized Life Sciences translation services in Europe.
Looking Ahead
The successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications is a milestone in our journey to provide best-in-class translation services for the Life Sciences sector.
It reaffirms our mission: to help clients achieve regulatory compliance, international growth, and safer healthcare outcomes through accurate and reliable multilingual communication.
Beyond Certifications: Active Engagement in the Life Sciences Community
At AbroadLink, our commitment to the Life Sciences and regulatory affairs sector in Europe extends beyond our certified processes. We actively contribute to the industry by sponsoring, exhibiting, and sharing knowledge at leading international events:
- Sponsorship and exhibition at the TEAM-PRRC Annual Summit (Rome 2025).
- Our sales team for France will attend the training session at La Rentrée du DM in October 2025.
- Sponsorship and exhibition at RAPS Euro Convergence – Brussels 2025 and Lisbon 2026.
- Exhibition at MEDICA Düsseldorf 2024 and 2025, one of the world’s leading medical trade fairs.
- Hosting an upcoming webinar with TEAM-PRRC: “Translation Under the MDR and IVDR: What a PRRC Should Know!”.
These initiatives reflect our commitment to staying at the forefront of European regulatory affairs, while providing clients with not just translations, but specialized regulatory solutions that support compliance and innovation in healthcare.
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With a background in Marketing and International Trade, Alex has always shown a passion for languages and an interest in different cultures. Originally from Brittany, France, he has lived in Ireland and Mexico before spending some time back in France and then settling permanently in Spain.
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