Regulated Document Translation API for Medical Devices
Ensure global compliance for medical devices. Bluente's API offers secure, ISO 27001 certified translation for technical docs, preserving layouts for faster regulatory submissions.
Test out our translation API
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A Compliant Translation API Built for Regulated Industries
Medical device teams face strict requirements when translating technical documentation for global markets. A missed table, broken numbering, or misaligned layout in a device manual or clinical submission can create costly delays or compliance failures.
Generic translation APIs process plain text and return broken files. Bluente is built differently. Its file-based API preserves the original structure of complex documents, including tables, charts, headers, legal numbering, and embedded images, across 22 formats and 100+ languages.
For regulated workflows, security is non-negotiable. Bluente is ISO 27001:2022 certified, SOC 2 compliant, and GDPR compliant, with end-to-end encryption and automatic file deletion after processing.
Whether you are translating device specifications, instructions for use, or clinical trial documents, Bluente integrates directly into your existing systems so your regulatory pipeline keeps moving.
What's included in our Translation API?
Our Translation API gives you fast, secure, and scalable access to high-quality translations across 120+ languages.
Our advanced terminology recognition delivers a 99.7% accuracy rate, trusted by lawyers and professionals who require precision.
Translation API
Fast, reliable translation API for seamless integration into your applications.
- 120+ Languages
Comprehensive language coverage for global reach
- RESTful JSON API
Simple integration with clear documentation
- End-to-end encryption
Secure data transmission and processing
- Batch upload with live status tracking
Process multiple files with real-time updates
- Webhook notifications for job completion
Get notified when translations are ready
- Multi-format support: DOCX, PDF, XML, JSON, images
Handle various file types seamlessly
- 99.9% uptime backed by global CDN
Reliable service with worldwide infrastructure
- Advanced layout formats & API configuration
Bilingual output, tracked changes, and layout preservation through API parameters
How it works
Our streamlined process delivers fast, accurate translations through our enterprise-ready API.
Review API Documentation
Explore our comprehensive API documentation, code examples, and integration guides to understand our translation capabilities and requirements.
Request for Trial Account
Contact our team to request a trial account. Provide your use case and integration requirements for review and approval.
Integrate and test
Build your integration using our RESTful API. Test and validate translations with your content.
Deploy and scale
Go live with confidence using our production-ready infrastructure. Monitor usage, track performance, and scale seamlessly as your needs grow.
Frequently Asked Questions
Get answers to common questions about our Translation API. Learn about supported languages, performance, integration options, and how to get started with our enterprise-ready solution.
Bluente's API supports 22 file formats including PDF, DOCX, DOC, PPTX, XLSX, XML, DITA, HTML, EPUB, INDD, AI, EML, SRT, and image formats such as PNG, JPG, and JPEG. This covers the full spectrum of technical documentation used in medical device regulatory submissions, from instructions for use to structured DITA content and scanned legacy files.
Bluente is ISO 27001:2022 certified, SOC 2 compliant, and GDPR compliant. These certifications reflect enterprise-grade security controls including end-to-end encryption and automatic file deletion. While Bluente provides secure, accurate, and format-preserving translations, your regulatory affairs team should verify submission-specific requirements with the relevant health authorities such as the FDA or CE notified bodies.
Yes. Bluente includes advanced OCR that converts non-selectable text in scanned PDFs and image files into editable, searchable, and translatable content, while preserving the original document structure. This is essential for processing legacy device files, scanned instructions for use, or older clinical documents that were not originally created as digital-native files.
Format preservation is a core capability of Bluente's API. Tables, charts, footnotes, numbering schemes, headers, footers, and embedded images are retained across all 22 supported file types. This means translated device specifications, labeling, and regulatory submissions are ready for review and filing without manual reformatting.
Bluente provides a RESTful JSON API that supports batch file uploads, real-time job tracking, and webhook notifications for job completions. Teams can integrate it directly into their document management systems, regulatory submission platforms, or internal pipelines. API access is granted after a review of your use case and integration requirements with the Bluente team.
Bluente supports 100+ languages, enabling medical device companies to prepare translated documentation for regulatory submissions and market distribution across major global regions, including the EU, US, Asia-Pacific, and beyond.
Bluente is built for enterprise confidentiality. All files are processed with end-to-end encryption and automatically deleted after processing. The platform holds ISO 27001:2022 certification, SOC 2 compliance, and GDPR compliance, making it appropriate for handling sensitive clinical trial documents, device specifications, and proprietary technical files.
Bluente's API is backed by a 99.9% uptime guarantee supported by a global CDN, ensuring your regulatory and technical translation workflows are not interrupted by service downtime. This reliability is critical for time-sensitive submission deadlines and large-scale batch translation jobs.
Contact Sales to Access the API
Speak to our team about your medical device translation requirements. We will review your use case and get you set up with API credentials and full documentation.
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