Case study: Linguistic validation of IFUs on a tight deadline

Executive Summary

The client, a manufacturer of laser therapy delivery devices, needed three user manuals translated into eight European languages. Devices sold in the European Union need to demonstrate full compliance with EU-MDR regulations. Therefore, translations for labeling and instructions for use (IFUs) require linguistic validation to ensure total accuracy. Linguistic validation adds an additional layer of quality assurance to guard against any errors that may lead to accidental misuse of the device.

The Challenge

Scriptis routinely performs linguistic validation for pharmaceutical and medical device clients. However, this project was unusual in its relatively short turnaround time. Linguistic validation requires more resources and complexity than a standard translation project, requiring expert project management to keep the process on track for completion.


Our standard ISO 17100-certified quality assurance process requires translation by a native language subject matter expert followed by review and proofreading by a second qualified linguist. In-house QA process provides a final check. After the manual was translated into eight languages following this standard process, linguistic validation began.

Linguistic validation takes different forms, including back translation and independent third party review.  After discussing the options with the client, the team combined both tactics for quickest turnaround.  The manuals were for three different models of the same type of device. Of the three manuals, two were almost identical except for a few sections. The third included more unique content. In consultation with the client, the PM decided to use back translation to validate the third manual. For the two similar manuals, we performed a full third party review for one and submitted the unique sections of the other for third party review as well. This hybrid approach cut costs and increased the odds that all eight languages would be finalized in time to meet the client’s deadline.

Back translation

The back translation process requires several steps. First, professional native English-speaking linguists translated the eight target translations “back” into English. Second, for each language, an independent third party compared the original source document with the back translation and flagged substantive differences. These differences were tracked by each reviewer and compiled into a report for the project team. The original translator then reviewed the points of difference and resolved them. We required eight different reconciliation editors because the time allotted for the reconciliation stage was especially short.

Third party review

For the third party review, eight additional professional linguists with subject matter expertise reviewed the translations against the source documents. Discrepancies were compiled in a report and then reconciled with the original translator. When performed by a professional linguist, third party review presents fewer complications than back translation. However, under certain circumstances, third party review can cause trouble and delay. This usually occurs when a client opts to review a translation internally by bilingual staff who are not professional translators. Read more about the potential pitfalls of third party review.


Careful planning paid off. The Scriptis project manager coordinated the linguistic validation done by the 24 independent linguists and reviewers. With no unexpected delays, the client received the validated translations within the necessary timeframe. Due to the complexity of the project, the client was even surprised to receive the documents on time, stating that other translation companies likely would have pushed the deadline. We continue to translate user interfaces, user manuals, and marketing content for this client.