A mistranslated warning in an instruction for use (IFU) can affect how someone operates a medical device. However, an error in a routine internal communication is unlikely to carry the same consequences. Yet both documents can follow the same translation process.
In one of our recent MDR and IVDR webinars, our medical device language expert, Eva Grassauer, and Florian Hefeter of QMD Services argued that medical device translation should be treated as “a controlled, risk-based quality process rather than simply a purchasing activity.”
This is especially important for medical device manufacturers, as poorly managed translation processes can introduce risks to patient safety and regulatory compliance.
The problem with inconsistent translation workflows
Two common approaches create unnecessary challenges.
In decentralized organizations, departments often choose their own translation providers and quality assurance processes. Decisions may be driven by cost, with limited consideration of the risks associated with the content. This could leave safety-critical documentation without adequate specialist review.
At the other extreme, some manufacturers apply the same rigorous workflow to every content type, regardless of its purpose. While this can strengthen quality controls, it also increases costs and turnaround times for content that carries relatively little risk.
A more effective approach starts with understanding the potential consequences of a translation error.
Applying risk management principles to translation
Medical device manufacturers are already familiar with ISO 14971, the international standard for medical device risk management. Its principles provide a useful framework for assessing translation-related risks.
The process begins by identifying potential hazards and assessing their consequences. Manufacturers can then determine appropriate controls, evaluate residual risks and document their decisions.
For translation, Eva recommends assessing content against two key factors:
- Patient safety: Could an incorrect or unclear translation contribute to device misuse or harm?
- Regulatory significance: Could a translation error affect compliance or the consistency of regulatory documentation?
Source text quality is also important. Ambiguous instructions or outdated terminology can introduce additional risks before translation even begins. This assessment helps manufacturers select appropriate workflows.
Safety-critical content, such as IFUs and product warnings, may require specialist human translation with independent review under ISO 17100. Lower-risk, repetitive content may suit AI translation with full post-editing under ISO 18587, subject to appropriate risk assessment and quality controls.
Why terminology and technology matter
Translation technology can improve efficiency, but its effectiveness depends heavily on the quality of the language resources supporting it.
As Eva explained during the webinar:
“Without well-maintained terminology, an AI translation may sound good and read fluently, but it can still be very difficult to select the correct technical terms.”
Approved terminology databases help maintain consistency across documents. Automated quality checks can flag issues such as missing numbers or incorrect placeholders, while qualified reviewers assess whether the translated instructions accurately convey the intended meaning.
A risk-based approach allows manufacturers to introduce automation where appropriate while retaining human oversight for higher-risk content.
Making translation decisions audit-ready
Every translation workflow should have a documented rationale. Manufacturers should be able to demonstrate why they selected a particular process, which quality controls they applied, who approved the content, and how they manage residual risks.
This creates a traceable process that supports quality management and audit readiness. Florian Hefeter reinforced the importance of preparation from a notified body’s perspective:
“Above all, the greatest gains in speed come from thorough preparation in the early stages.”
Building translation risk assessments into established quality management processes helps manufacturers make these decisions earlier, reducing avoidable rework and giving teams greater control over multilingual documentation.
