Blog on translation, regulation & language

Practical insight for teams working across languages and borders — from language requirements and technology to international marketing and the cultural detail that makes localization work.

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Medical devices

Is it mandatory to use ISO 13485-certified translation providers under the MDR?

Is ISO 13485 mandatory for translating medical devices under the MDR? Discover what the regulations actually require and when certification is needed.

JG Josh Gambín 13 Oct 2026 5 min read

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Medical devices

Is AI translation compliant with the MDR/IVDR for medical devices?

AI translation meets MDR/IVDR requirements when integrated into a validated quality system with structured human review. Build audit-ready workflows that guarantee accuracy, full traceability, and regulatory confidence.

JG Josh Gambín 22 Apr 2026 11 min read

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AbroadLink News

Translation industry in Europe: what the ELIS 2026 report reveals

The ELIS 2026 report maps a market shifting from volume to value, demonstrating how specialization, ISO standards, and expert oversight secure competitive advantage in AI-driven regulated workflows.

ALB Alex Le Baut 1 Apr 2026 6 min read

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Blog on translation, regulation & language

Is it mandatory to use ISO 13485-certified translation providers under the MDR?

Is AI translation compliant with the MDR/IVDR for medical devices?

Translation industry in Europe: what the ELIS 2026 report reveals

Latest articles

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