IFU Translation for Medical Software (SaMD)
Localize software UIs and instructions for use in full regulatory compliance
Software as a Medical Device: A new dimension of translation
The digitalization of healthcare has made Software as a Medical Device (SaMD) one of the fastest-growing categories in the medical device industry. From diagnostic algorithms to clinical decision support systems to patient monitoring software — the range is enormous. What all these products share: they must be delivered with instructions for use in the official language of each target market under EU MDR 2017/745. And with software, the user interface adds an additional translation object.
The dual challenge: UI localization and IFU translation
Unlike physical medical devices, SaMD has a direct connection between the user interface and the instructions for use. IEC 62366-1 requires that the interplay between product and accompanying documentation supports usability and minimizes use errors. In practice, this means: if the software labels a button "Start Measurement," the instructions for use must use exactly that term — in each of the 24+ target languages.
This requirement is frequently violated in practice because UI strings and documentation are translated in separate systems by different teams. The result is inconsistencies that surface during usability testing — or worse: during audits by Notified Bodies.
Regulatory framework for SaMD translations
The MDR classifies software under Rule 11, which provides a tiered system based on intended purpose. Software intended to provide information used for therapeutic or diagnostic decisions is classified as at least Class IIa. For potentially life-threatening decisions, the classification rises to Class III.
For translation, this means: the higher the class, the stricter the requirements for the translation process. Class III software requires a fully documented translation workflow with four-eyes review, subject matter verification, and regulatory approval. Additionally, the requirements of IEC 62304 for the software life cycle apply, which also encompass the localization process.
Agile development meets regulatory translation
Most SaMD manufacturers develop using agile methods — with sprint cycles of two to four weeks and continuous releases. The translation of UI strings and instructions for use must be integrated into this rhythm without slowing it down. manualworks addresses this challenge through automatic detection of changed content, parallelized translation workflows, and the ability to integrate into existing CI/CD pipelines.
manualworks: Built for SaMD industry requirements
manualworks unifies UI localization and IFU translation in a single platform. The shared terminology database ensures that terms in the software interface and documentation are translated identically. The segment-based approach enables reuse of previously translated content with each new revision. And the configurable workflows map exactly to the different requirements of MDR risk classes.
For Regulatory Affairs managers, this means: a single system for the entire localization process, full traceability of all translation decisions, and an audit trail that meets the requirements of ISO 13485 and IEC 62366-1.
Frequently Asked Questions
What specific requirements apply to translating software IFUs under IEC 62366?+
IEC 62366-1 (Usability of medical devices) requires that the user interface and associated documentation are designed to minimize use errors. For translations, this means: UI strings, error messages, warnings, and instructions for use must be translated so they are equally clear and unambiguous in every target language. manualworks enables parallel management of UI strings and IFU content with shared terminology.
Can manualworks manage software UI strings and IFU documents in a single project?+
Yes. manualworks supports the parallel management of different document types within a single project. UI strings, online help, instructions for use, and quick start guides can be linked to a shared terminology database. This ensures that terms like "measurement result" or "patient record" are translated identically in the software interface and its accompanying documentation.
How does manualworks support the agile development process of medical software?+
Medical software is increasingly developed using agile methods, with frequent releases and incremental changes. manualworks supports this process through automatic detection of changed segments with each revision, so only actual text changes are queued for translation. The platform can be integrated into existing CI/CD pipelines, enabling continuous localization in parallel with the development process.