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Building Translation Pipelines for Regulatory Compliance: A Developer's Guide to FDA and FCC Documentation

DEV Community·Diogo Heleno·25 days ago
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Building Translation Pipelines for Regulatory Compliance: A Developer's Guide to FDA and FCC Documentation When your company ships hardware or medical devices to the US market, you'll inevitably hit a wall of regulatory documentation that needs precise English translations. Having worked on internationalization systems for regulated industries, I've learned that the technical challenges go far beyond just converting text from one language to another. This article covers the technical considerations for building translation workflows that meet FDA and FCC requirements, based on real-world experience with regulatory submission pipelines. Why Standard Translation APIs Fall Short Most developers' first instinct is to reach for Google Translate API or AWS Translate. For regulatory documents, this approach will get your submission rejected. FDA and FCC submissions require what's called "certified translation" — each document needs an accuracy statement from a qualified translator.…

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