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Project Assessment
We review the IFU, available source language content, reference documentation, terminology and project requirements to define the appropriate workflow.
Services
We provide IFU Content Optimisation and Regulatory Support before translation begins, helping manufacturers establish clear, consistent and translation-ready source content for use across international markets.
How We Work
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We review the IFU, available source language content, reference documentation, terminology and project requirements to define the appropriate workflow.
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Native English and bilingual medical device linguists improve linguistic clarity, technical accuracy, consistency and translatability. Where included, experienced QA/RA consultants provide regulatory and safety-related input.
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The manufacturer reviews the findings, clarifies product-specific requirements and approves the recommendations to be implemented.
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Approved changes and stakeholder feedback are incorporated, followed by final linguistic, terminology, formatting and implementation checks before delivery.
Our detailed IFU Optimisation Workflow and Service Level Agreement are available to prospective clients upon request.
Request the Detailed Workflow and SLA
Usability
Where required, optimised and translated IFUs and other user-facing materials can also be considered as part of medical device usability testing, coordinated through experienced specialist usability and human-factors partners.
In Practice
Learn how source content quality, regulatory context, terminology, review requirements and intended use influence the appropriate workflow for IFUs and other regulated medical device documentation.
Resources
Access practical guidance, case studies and supporting materials for medical device and IVD content.
Questions
What is IFU content optimisation?
IFU content optimisation improves the clarity, readability, terminology, consistency, structure, regulatory alignment and translatability of Instructions for Use before translation and use across international markets.
When should an IFU be optimised?
IFU content optimisation is particularly valuable before translation and use across international markets, especially where the source content contains inconsistent terminology, ambiguous instructions, structural issues or potential regulatory concerns.
How do you preserve the meaning of the original source language IFU?
Native English and bilingual medical device linguists work together to improve the English content while checking it against the original source language document. This helps maintain technical accuracy and identify omissions or unintended changes in meaning.
What does regulatory support include?
Where included, experienced QA/RA consultants review agreed aspects of the IFU and provide regulatory, safety and structural observations. The manufacturer retains responsibility for final content decisions, regulatory compliance and submission or approval of the documentation.
Can we begin with a pilot project?
Yes. A paid pilot can apply the proposed workflow to an agreed section of the IFU, allowing your team to evaluate the methodology, recommendations, collaboration process and deliverables before proceeding with the complete document.
Contact us to discuss your device, source language documentation, regulatory support requirements, target markets and planned translation timeline.