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Translation of IFU

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ECS Created:   Sep 23, 2021 Last commented:   Sep 24, 2021

Translation of IFU

In order to have your instructions for use translated you have to ensure that the translation is correct a professional.

We have a class III product only used by HCP's. We use a certified translation company who dispatches translation certificates (translated by native speaker with knowledge of the specific discpine and reviewed by a second reviewer).

Is it correct that after the IFU has been translated an additional validation needs to be done of the translation by a subject matter expert (HCP) for each language?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 24, 2021

There is no strict requirement that translation validation must be performed. However, from the ISO 13485 point of view, validation must be performed for all processes where the resulting output cannot be monitored or measured by subsequent monitoring or measurement. Translation validation will ensure that each time translations will be provided in a proper manner and that information provided in the IFU are correct. It should be done once and there is no need for another validation while native speakers do not change.  

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Sep 23, 2021

Sep 24, 2021

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