High-Accuracy AI Translation for Medical Device Documentation

For medical device technical files, the best tools combine domain-specific AI with robust quality controls. X-doc AI is trained on millions of life sciences documents, ensuring 99%+ accuracy for terminology in IFUs, design dossiers, and risk management files. Our layout-preservation engine maintains the integrity of complex tables, diagrams, and formatting required by standards like ISO 13485.

We ensure compliance through a multi-layered approach: domain-trained AI for terminology accuracy, customizable glossaries to enforce consistency, a quality management system (QMS), and an optional human-in-the-loop review by subject-matter experts. This process is designed to meet the stringent requirements of regulatory bodies like the FDA (for 510(k) or PMA submissions) and EU authorities (for MDR/IVDR).

Preserving formatting in IFUs and labels is critical for patient safety. X-doc AI uses advanced layout analysis to replicate the source document's structure, including warnings, multi-column layouts, tables, and embedded graphics. This eliminates manual rework and ensures the translated document is clear, usable, and compliant.

Our software localization process is designed for accuracy and usability. It includes extracting text strings from your source code, AI-powered translation with terminology management, and re-integrating the translated strings. We account for UI element resizing and provide context to translators to ensure the final interface is intuitive for clinicians and patients in every target language.

Yes. We provide certified translations for all clinical trial documentation, including Informed Consent Forms (ICFs), protocols, and investigator brochures. Our certified translations are performed by accredited linguists and include a certificate of accuracy, ensuring they are accepted by Institutional Review Boards (IRBs) and ethics committees worldwide.