IFU-Anatomie

Anatomy of a Software as Medical Device (SaMD) IFU

Interactive Document Dissection: From System Requirements to Cybersecurity – The Unique Translation Challenge of Medical Software

This section lists the technical prerequisites for operating the SaMD: supported operating systems and minimum versions, hardware requirements (processor, RAM, storage, screen resolution), network requirements, supported browsers and versions, and compatible medical devices and interfaces (HL7, FHIR, DICOM). Compatibility information is frequently presented in tabular form.

Challenge

IT terms like "cloud-hosted," "on-premise," "single sign-on," or "two-factor authentication" are used as English loanwords in some languages, partially or fully translated in others. The decision whether "Firewall" appears in the target language as "Firewall" or as a local-language equivalent must be made consistently throughout the entire document and the software UI.

Solution with manualworks

manualworks maintains a language-specific IT terminology database that specifies for each target language whether an IT term is translated, adopted, or used in a hybrid form (e.g., "two-factor authentication"). Terminology is automatically aligned with the software UI localization to ensure consistency between the application and its IFU.

Frequently Asked Questions

What makes translating a SaMD IFU particularly challenging?+

SaMD IFUs combine three specialized domains that rarely appear together in traditional IFUs: medical terminology, software terminology, and data privacy/cybersecurity legal language. The software user interface must exactly match the IFU description, UI texts must be consistent across all languages, and terms like "Clinical Decision Support" or "Machine Learning-based algorithm" require careful balancing between technical accuracy and user comprehensibility.

Does every software update require retranslation of the entire IFU?+

No, but every significant change according to Article 120 MDR and MDCG 2020-3 Guidance requires assessment of whether the change affects translations. manualworks automatically identifies which IFU sections are affected by a software change and creates a targeted update task only for the modified segments. This significantly reduces translation effort for frequent software updates while ensuring that no safety-relevant change is overlooked in any language version.

How are GDPR notices in SaMD IFUs harmonized across different languages?+

GDPR notices in SaMD IFUs must consider both the EU-wide regulation and national implementation laws (e.g., BDSG in Germany, Loi Informatique et Libertes in France). manualworks provides country-specific GDPR text modules pre-validated by data protection attorneys. Terms like "data processing agreement," "data subject rights," or "data portability" are sourced from a legally reviewed terminology database.

Ready for better IFU translations?

Try manualworks for free — no credit card required.