Medical Devices
Making Complex Medical Device Instructions Clear Across Languages
Project Overview
ABS Dezign engaged our team to support Medtronic with multilingual translations and clarity-focused revisions for the Intersept® Cardiotomy Reservoir product line. These documents contain dense technical descriptions, warnings, regulatory language, and step-by-step procedural instructions used in operating rooms and intensive care units worldwide.
Our goal was to support Medtronic’s teams by creating high-quality, medically accurate translations while also improving readability and user comprehension—without compromising regulatory intent or device-specific precision.
Representative Examples of Content We Translated
General descriptions—not reproducing proprietary text:
Multi-port reservoir diagrams and part numbers
Detailed component descriptions (e.g., defoaming layers, tricot sleeves, outlet configurations)
ICU autotransfusion procedures
High-risk warnings (air embolism, vacuum limits, sterility guidance)
Indications, contraindications, and precautions
Limited warranty language for US and non-US markets
The Intersept® reservoir IFUs contain:
Highly technical device descriptions (e.g., multi-port configurations, microaggregate filtration systems)
Complex warnings tied to patient safety (air embolism, vacuum pressure limits, anticoagulation requirements)
Stepwise OR and ICU procedures requiring exact sequencing
Specialized terminology and units of measure
Variants by model (1350, 1351, CB1351) with distinct features and indications
Regulatory constraints requiring consistent terminology and labeling alignment across languages
Medtronic needed translations that were both linguistically correct and functionally accurate, clinically safe, and usable across international markets.
1. Terminology Foundations & Device Familiarization
We built a multilingual terminology base informed by:
Medtronic’s internal lexicons
ISO-standard medical terminology
Cardiopulmonary bypass vocabulary
Device-specific phrasing (“defoamer,” “filtered prime port,” “air/fluid separation chamber,” etc.)
This ensured consistency across all models and all target languages.
2. Structured Translation Workflow for High-Risk Medical Content
We applied a medical-grade translation process:
Source analysis: Identified high-risk segments (warnings, contraindications, ICU protocols).
Primary translation: Native translators with cardiology/cardiovascular specialization.
Medical review: Bilingual subject-matter experts validated clinical meaning.
Regulatory alignment: Ensured phrasing met regional device labeling expectations.
Quality checks: Verification of units, measurements, figure references, port labels, and procedural sequences.
Layout-aware proofing: Ensured text fit within labeling templates without altering meaning.
3. Expansion to Additional Languages
The project began with Spanish and French, then expanded to:
Italian • German • Portuguese • Hebrew • Czech
Russian • Vietnamese • Chinese • Greek • Arabic
For each new language, we scaled the terminology base and ensured cross-language harmonization—critical for global product families.
✔ Accurate, clinically safe multilingual translations
All languages passed Medtronic’s internal quality and regulatory review on first submission.
✔ Improved clarity and usability
Feedback from clinical and training teams noted clearer step sequences and fewer interpretation concerns.
✔ Reduced translation rework
Terminology harmonization significantly lowered future translation costs and inconsistencies.
✔ Ready-to-publish IFUs for global markets
Final deliverables followed Medtronic formatting, labeling, and compliance requirements.
✔ Scalable model for other product families
This workflow is now used for additional devices within the cardiopulmonary portfolio.
Service Categories
This case study includes:
Medical Translation • Technical Documentation • Terminology Development • Content Clarity & Optimization • Regulatory Language Support • Multilingual Quality Assurance
Why It Matters
Clear, accurate instructions support:
Safe clinical use during highly time-sensitive procedures
Reduced risk of misinterpretation in multi-lingual OR and ICU teams
Regulatory compliance across markets
Better patient outcomes through consistent device handling
For global medical devices, clarity is not optional—it’s a safety imperative.
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