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Why Language Accuracy Matters in Diagnostic Imaging

Why Language Accuracy Matters in Diagnostic Imaging

In diagnostic imaging, precision is paramount. The accurate interpretation of MRI, CT, X-ray, ultrasound, and PET-CT scans directly informs clinical decisions and patient outcomes. As these technologies are deployed globally, manufacturers must ensure that all accompanying content, user manuals, software interfaces, safety labeling, and regulatory documentation, is linguistically accurate and culturally adapted for each target market.

Diagnostic imaging systems involve highly complex technology, often incorporating advanced software, AI algorithms, and integrated workflow solutions. Translating this content requires more than language fluency. It demands subject matter expertise in radiology, medical physics, and device-specific functionality to avoid ambiguities that could compromise clinical performance or user safety.

International regulatory bodies, including the FDA, EMA, and PMDA, require multilingual compliance for product labeling, instructions for use (IFUs), and electronic interfaces. Errors or inconsistencies in translation can delay product approvals, lead to costly recalls, or expose patients to risk.

At Sesen, we understand that diagnostic imaging translation is not just about words. It is about preserving diagnostic accuracy, maintaining compliance, and ensuring safe operation of medical imaging equipment worldwide.

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Types of Diagnostic Imaging Devices We Support

Types of Diagnostic Imaging Devices We Support

Sesen provides expert translation services for a wide range of diagnostic imaging systems used in hospitals, outpatient centers, and clinical research environments. Our linguists specialize in translating complex medical and technical content tailored to the unique specifications of each imaging modality. We support global manufacturers seeking accurate, compliant, and localized content for international deployment.

Supported Device Categories

Translation of safety manuals, software interfaces, coil configuration guides, and noise exposure warnings for high-field and low-field MRI units.

Localization of installation manuals, scan protocol documentation, 3D imaging software, and radiation safety labeling for both stationary and portable CT devices.

Multilingual translation of operator instructions, real-time imaging system interfaces, calibration procedures, and digital radiography components.

Translation of touch-screen software, transducer setup guides, doppler imaging configurations, and point-of-care diagnostic workflows.

Localization of hybrid PET imaging systems, tracer safety instructions, and nuclear medicine operation documentation.

Translation of screening and diagnostic system documentation, compression mechanics, image acquisition protocols, and regulatory labeling.Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Multilingual support for SPECT scanners, gamma camera systems, radiopharmaceutical handling, and imaging reconstruction software.

Integrated translation services for dual-modality systems, including hardware synchronization protocols and fused image post-processing software.

Use Case-Specific Translation Solutions

High-precision localization for magnetic safety zones, RF shielding, and emergency stop procedures.

Translation of detailed instructions for CT image acquisition, gantry positioning, and patient radiation protection.

Accurate localization of ultrasound GUI elements, presets, and color flow imaging tools.

Translation of clinical evaluation reports, technical files, and labeling documentation for FDA, EU MDR, NMPA, and other market approvals.

Types of Diagnostic Imaging Devices We Support

Documents We Translate for Diagnostic Imaging Devices

Sesen delivers high-quality translation services across the full documentation lifecycle of diagnostic imaging systems. From regulatory submissions to multilingual software UI, our work supports global market access, clinical usability, and patient safety. We group our expertise into four core categories to align with your internal teams and functional workflows.

We support manufacturers in meeting international market entry requirements by translating regulatory content with precision and consistency. Our work complies with ISO 13485, ISO 17100, and regional language regulations for medical devices.

  • CE mark labels and IFU translations for EU MDR submissions
  • FDA 510(k), PMA, and De Novo application content
  • Unique Device Identification (UDI) and Global Medical Device Nomenclature (GMDN) entries
  • General Safety and Performance Requirements (GSPR) and Essential Requirements documents
  • Clinical evaluation reports and technical documentation for notified body review

Sesen specializes in translating complex technical documents that guide system installation, configuration, and maintenance. We work with engineering and quality teams to ensure that translated content aligns with device-specific terminology and operational accuracy.

  • Installation manuals and calibration procedures
  • Operation guides for radiographers, engineers, and biomedical technicians
  • Service manuals and preventive maintenance documentation
  • Technical specification sheets and hardware integration instructions
  • DICOM conformance statements and image protocol documentation

We localize imaging software interfaces and embedded system controls with full in-context QA, ensuring seamless user experience across languages. Our process supports both static interfaces and dynamic software applications.

  • Touchscreen UI elements for ultrasound, CT, and MRI systems
  • Control panel commands, status messages, and system prompts
  • Error codes, diagnostic alerts, and troubleshooting instructions
  • Imaging workflow applications and data management modules
  • Radiology PACS system integration interfaces

Sesen provides professional translation of client-facing and internal materials to support product marketing, distributor enablement, and operator training. All content is localized for cultural relevance and clinical accuracy.

  • Brochures, catalogs, and product datasheets
  • eLearning modules and technician training guides
  • Video subtitles and voiceover scripts for system demos
  • Patient-facing documents, including exam prep and aftercare instructions
  • Presentations and sales enablement collateral
Our Quality-Centric Translation Workflow

Our Quality-Centric Translation Workflow

Sesen’s translation workflow is purpose-built to support the complex demands of diagnostic imaging device manufacturers. From initial file preparation to post-market updates, our process is engineered to meet regulatory requirements, ensure medical accuracy, and deliver linguistically validated content across global markets. Every step is designed to minimize risk, maintain consistency, and support fast, compliant product launches.

Our team conducts a detailed assessment of source files, extracting key terminology and identifying potential translation challenges. We align with your internal glossaries and product-specific language preferences to build a strong foundation for consistency and compliance.

  • File preparation and formatting
  • Terminology extraction and alignment
  • Reference material analysis
  • Regulatory scope identification

We assign professional translators who are both native speakers and subject matter experts in diagnostic imaging, radiology, and medical device technology. Each linguist is vetted for experience with Class II and Class III devices and trained in regulatory terminology.

  • Native-speaking professionals with domain expertise
  • Medical physics, radiology, and device experience
  • Language and market alignment for target region

Our ISO 17100-certified translation process follows a three-step TEP workflow: translation, editing, and proofreading. Each project undergoes multi-level linguistic and technical validation to ensure clarity, consistency, and compliance.

  • First-pass translation using validated terminology
  • Editorial review for accuracy and tone
  • Final proofreading for grammar, formatting, and flow

We conduct in-context QA for user interfaces, software strings, and labeling layouts. Our linguists review content within real product environments or simulated UI to ensure translations fit space constraints and maintain usability.

  • UI and touchscreen interface QA
  • Label layout review for multilingual expansion
  • Functional and contextual validation

Clients receive clean, formatted deliverables aligned with their documentation and regulatory requirements. We accommodate feedback, style guide updates, and internal review cycles as part of the delivery process.

  • Final files delivered in requested format
  • Client comments integrated
  • Regulatory references preserved and traceable

Sesen provides ongoing translation support for software updates, documentation revisions, and global change control. We maintain translation memories and termbases to reduce costs and improve efficiency over time.

  • Update management and version tracking
  • Change control support for IFUs and labels
  • Continuous improvement through TM and QA feedback loops
Regulatory Compliance and Certifications

Regulatory Compliance and Certifications

Sesen delivers diagnostic imaging translation services with a strong foundation in global regulatory compliance. Our processes are certified under ISO 13485:2016 for medical device quality management and ISO 17100 for translation service standards, ensuring that every project meets the rigorous demands of the healthcare industry. We work in alignment with regional regulations, including the European Union Medical Device Regulation (EU MDR), In Vitro Diagnostic Regulation (IVDR), and multilingual submission requirements for the FDA, MHRA, NMPA, and PMDA.

Our team is experienced in translating critical documentation such as General Safety and Performance Requirements (GSPR), Unique Device Identification (UDI) files, and clinical evaluation reports. We develop and maintain translation memories and client-specific glossaries to ensure long-term consistency, reduce approval delays, and support traceability in regulatory audits. Whether for 510(k) filings, CE mark submissions, or labeling verification, all translations undergo dedicated linguistic and regulatory review to meet notified body expectations and streamline market access.

Why Sesen for Diagnostic Imaging Translation

Why Sesen for Diagnostic Imaging Translation?

Sesen is a trusted partner for global diagnostic imaging manufacturers seeking high-quality, regulatory-compliant translations. Our exclusive focus on life sciences allows us to bring unmatched domain expertise to every project. With deep experience supporting Class II and Class III diagnostic devices, we understand the complexity of radiological systems and the precision required in localizing technical content, user interfaces, and regulatory documentation.

Our linguists are not only native professionals but also possess specialized backgrounds in radiology, biomedical engineering, and medical physics. This ensures that translations are both linguistically accurate and technically sound. Sesen has a proven track record delivering high-volume, multilingual projects for some of the world’s leading medical imaging companies.

We offer in-context UI software translation capabilities through our proprietary Stepes TMS, enabling real-time review of embedded strings and interface layouts. Our infrastructure supports scalable, multi-country rollouts with consistent terminology and formatting. Each project is managed by a dedicated life sciences project manager who oversees all phases from kickoff to final delivery, ensuring transparency, accuracy, and responsiveness at every step.

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Case Studies and Client Success Examples

Case Studies and Client Success Examples

Sesen has successfully supported leading diagnostic imaging manufacturers with high-impact translation projects that meet tight timelines, complex technical requirements, and strict regulatory standards.

In one recent project, we managed the European rollout of a next-generation AI-enabled CT scanner for a global device manufacturer. The engagement involved translating regulatory labels, software UI elements, and supporting documentation into 12 languages. Leveraging our in-context software localization tools and experienced radiology linguists, we delivered all materials within four weeks, meeting the client’s launch schedule and multilingual compliance requirements.

Another success involved the localization of a 200-page MRI operation manual for international distribution. The project included full document translation, desktop publishing in InDesign, and PDF formatting for bilingual output. Our linguists performed in-depth linguistic QA and technical validation to ensure accuracy, consistency, and proper alignment with the client’s engineering documentation.

These projects reflect Sesen’s ability to manage multilingual diagnostic imaging translation at scale while maintaining the precision, speed, and compliance needed for international medical device markets.

Frequently Asked Questions

Diagnostic imaging documentation should be translated by professional linguists with proven expertise in medical devices, radiology, and regulatory affairs. Sesen assigns native-speaking subject matter experts who are experienced in translating installation manuals, IFUs, software interfaces, and clinical labeling for imaging systems. Our ISO 13485 and ISO 17100 certifications, combined with regulatory knowledge of EU MDR, FDA 510(k), and regional language mandates, ensure that all deliverables support compliant market entry and pass notified body review.

Yes. Sesen specializes in localizing embedded software and touchscreen user interfaces for CT, MRI, ultrasound, and other imaging systems. We use in-context UI review tools that allow linguists to visualize the interface in real time and ensure proper text fit, functionality, and user clarity across languages.

Our translations support compliance with international medical device regulations, including EU MDR, IVDR, FDA 21 CFR Part 820, and regional language requirements from authorities such as MHRA, NMPA, and PMDA. We are certified under ISO 13485 for medical device quality management and ISO 17100 for translation services.

Yes. Sesen translates DICOM conformance statements and related image communication protocols with accuracy and consistency. Our linguists are trained to handle the specialized language of imaging standards, including tag-level metadata and interoperability specifications.

We provide ongoing translation support for software updates, documentation revisions, and change-controlled labeling. Our translation memory and terminology systems ensure consistent language across versions, while our project teams deliver rapid turnaround for time-sensitive updates.

Explore Related Life Sciences Translation Services

  • End-to-end translation solutions for Class I, II, and III medical devices, including technical documentation, regulatory submissions, and multilingual labeling, tailored for global market entry.
  • Accurate and compliant translation of Instructions for Use across languages and regions, with formatting and layout support for printed and digital distribution.
  • Multilingual translation of product labels, folding cartons, and blister packaging that meets regional regulatory requirements and readability standards.
  • Specialized translation support for study protocols, informed consent forms, and trial documentation to accelerate clinical development timelines and meet ethics committee requirements.
  • Expert review and QA of translated content for accuracy, terminology consistency, and regulatory alignment before final approval or market release.

Let’s Talk About Your Diagnostic Imaging Translation Needs

Ready to expand into new markets with accurate, compliant, and high-quality translations for your diagnostic imaging systems? Whether you need multilingual documentation for MRI and CT scanners or software localization for imaging workflows, Sesen provides expert language solutions tailored for global medical device manufacturers.

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