Medical Device IFU Translation — Saudi SFDA Registration (Critical Safety Document)
Translate a medical device Instructions for Use (IFU) into Arabic compliant with SFDA requirements and ISO 15223, with back-translation protocol for critical safety items.
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#IFU#SFDA#أجهزة طبيّة#ISO 15223#سلامة#تسجيل دوائي
Built-in quality guards
Accuracy
Complete and faithful transfer of meaning, no omission or addition
Fluency
Translated text reads naturally in target language
Terminology
Specialized terms are accurate and consistent
Cultural Equivalence
Cultural concepts are equivalenced, not literal-translated
KSA Compliance
Official documents comply with Saudi authority requirements