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Why Specialized Translation Matters for Cardiovascular Devices

Cardiovascular medical devices are among the most highly regulated products in the global healthcare market. In regions such as the United States and the European Union, these products are typically classified as Class II or Class III, meaning they pose moderate to high risk to patient safety. Inaccurate translations of Instructions for Use (IFUs), regulatory submissions, or patient-facing documentation can lead to serious consequences, including device misuse, regulatory rejection, or market withdrawal.

Global health authorities such as the FDA, EMA, and notified bodies under the EU MDR mandate that all documentation be linguistically accurate, technically precise, and fully validated in the target market language. Compliance is not optional but a prerequisite for product approval and continued market access.

Sesen brings deep domain expertise in cardiovascular device translation, backed by ISO 17100 and ISO 13485 quality certifications. Our linguists are trained in clinical terminology, device-specific nomenclature, and evolving global regulatory frameworks. Whether translating IFUs for a pacemaker, DFUs for a vascular graft, or multilingual e-labeling content for a cardiac monitoring platform, we ensure every deliverable meets the highest standards for accuracy, clarity, and regulatory readiness.

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Types of Cardiovascular Devices We Support

Sesen provides professional translation services for a wide range of cardiovascular medical devices, helping manufacturers ensure accurate multilingual communication across regulatory, clinical, and commercial channels. Our linguists are experienced in device-specific terminology, labeling conventions, and classification criteria used by regulatory bodies such as the FDA and EU MDR.

We support translation and localization for the following cardiovascular device categories:

Includes single- and dual-chamber pacemakers, leadless pacemakers, cardiac resynchronization therapy (CRT) systems, and implantable defibrillators for arrhythmia management. Translations cover IFUs, device labeling, patient booklets, and surgical guides.

Support for bare metal, drug-eluting, and bioresorbable stents used in coronary and peripheral arteries. We translate technical documentation, regulatory submissions, product inserts, and digital instructions.

Covers both transcatheter and surgical valve replacement and repair systems, including TAVR and mitral valve platforms. Sesen provides translations for DFUs, surgical protocols, and multilingual labeling.

Translation support for radiofrequency, cryoablation, and pulsed field ablation devices, including catheter handling instructions, safety warnings, and EP lab training manuals.

Includes synthetic vascular grafts, arterial closure systems, and bioabsorbable sealing technologies. We translate IFUs, labeling, and compliance documentation for EU MDR and FDA markets.

Holter monitors, wearable ECG patches, and implantable loop recorders are covered. Translations extend to patient-facing instructions, clinician setup guides, and post-market surveillance forms.

Wearables for heart rate, rhythm tracking, and mobile ECG monitoring. We translate app interfaces, user manuals, Bluetooth pairing instructions, and multilingual product packaging.

Covers diagnostic catheters, 3D cardiac mapping software, and hardware systems used in electrophysiology labs. We provide translations for UI strings, procedure workflows, and product documentation.

Sesen’s expertise extends across both Class II and Class III cardiovascular systems, including implantable, minimally invasive, and software-enabled devices. Whether for CE marking, FDA submission, or global market adaptation, we ensure all content is accurately translated and fit for regulatory and clinical use.

Document Types We Translate

Sesen delivers high-quality translations for all document types required throughout the cardiovascular device product lifecycle. From early-stage clinical development to global market launch and post-market surveillance, we support comprehensive multilingual documentation in compliance with international regulatory standards.

Accurate translation of printed and electronic IFUs is critical for device safety and global compliance. We ensure terminology precision, layout consistency, and readability in all target languages.

We translate DFUs for both surgical and implantable cardiovascular devices, following formatting guidelines and risk communication standards outlined in ISO 20417 and ISO 15223-1.

Includes CE marking technical files, FDA 510(k) premarket notifications, PMA submissions, and global registration documents. Our regulatory linguists follow strict confidentiality protocols and adhere to country-specific submission formats.

We translate high-risk product labeling content, including cautionary statements, dosage instructions, and graphical symbols. Deliverables are aligned with EU MDR, FDA UDI, and ISO 15223-1 requirements.

Support for electronic instructions and multilingual labeling hosted on digital platforms. We localize both content and metadata in compliance with EU Commission Regulation 207/2012 and applicable FDA guidance.

Localization of software user interfaces for implantable and wearable monitoring systems, mobile apps, and cloud-based platforms. We provide in-context translation to ensure clarity and functionality in all languages.

We translate technical training guides for clinicians, operating room teams, and field engineers. Clinical documentation is reviewed by subject matter experts to ensure accuracy in therapeutic terminology and procedural detail.

Culturally and linguistically adapted translations that meet health literacy and regulatory readability standards. Our translations support patient comprehension and comply with IRB, GDPR, and HIPAA guidelines.

We provide professional translations for brochures, product videos, web content, and sales enablement materials, ensuring message consistency across multilingual markets.

Translation of risk analyses, failure mode reports, and mitigation strategies per ISO 14971. Content is processed with confidentiality and regulatory precision to support audit-readiness and traceability.

Regulatory Knowledge You Can Trust

Sesen delivers cardiovascular device translations that meet the highest regulatory standards in every target market. Our workflows are designed to support global market approval and post-market compliance, with full alignment to regional and international regulatory frameworks. We work closely with regulatory affairs teams, clinical specialists, and quality managers to ensure that every translation is accurate, validated, and audit-ready.

Our translation process supports the following key standards and requirements:

We translate documentation in compliance with EU MDR Annex I, including General Safety and Performance Requirements (GSPRs) and multilingual labeling mandates. Our team stays current on evolving requirements for eIFUs, readability, and device classifications.

Sesen supports FDA requirements for medical device labeling, software content, and UDI data submission. We ensure accurate translation of instructions, interface text, and safety information for Class II and Class III cardiovascular devices.

Our quality management system follows ISO 13485 standards for medical device design, production, and lifecycle documentation. Translation deliverables meet traceability, risk management, and document control expectations.

Translations reflect standardized terminology and symbols as defined in ISO 15223-1. We verify that all risk and safety messaging is consistent, culturally appropriate, and regulator-approved in each market.

Sesen is certified to ISO 17100 for translation services, which ensures the use of qualified linguists, peer-reviewed editing, and defined quality assurance procedures across all projects.

Our translators are trained in controlled vocabularies such as MedDRA and SNOMED CT, ensuring consistency in clinical, safety, and adverse event reporting language across regulatory submissions.

We adhere to national guidelines for translation readability and patient comprehension, including requirements from ANSM (France), BfArM (Germany), AIFA (Italy), and other competent authorities. For patient-facing materials, we offer optional linguistic validation services to support IRB and ethics board submissions.

Quality Process and Team Expertise

At Sesen, quality is embedded into every stage of the cardiovascular device translation process. Our team is composed of highly trained professionals with deep expertise in regulatory, clinical, and technical documentation specific to Class II and Class III medical devices. Each translation undergoes a structured quality assurance workflow designed to meet global compliance requirements and client-specific quality expectations.

All translations are performed by qualified native speakers with proven experience in cardiovascular device terminology, anatomy, and procedure-specific content. We assign linguists based on therapeutic area expertise and regulatory familiarity.

Each project includes review by bilingual SMEs with clinical or regulatory backgrounds. SME review ensures the use of accurate medical terminology and alignment with labeling conventions and safety-critical communication standards.

Our process includes initial translation, peer review, medical QA, and final linguistic quality assurance (LQA). Automated checks are conducted using QA tools to identify errors in terminology, numbers, units of measure, and formatting.

We develop and maintain project-specific termbases and translation memories to ensure consistency across product lines, documentation types, and global markets. Client-approved glossaries and legacy materials are integrated into every project.

Translations are delivered in production-ready formats with full support for structured layouts, multilingual desktop publishing, and regulatory label templates. Our DTP team ensures alignment with source formatting, including symbols and graphical elements.

We provide optional in-country review workflows for clients requiring internal validation. All reviewer edits are reconciled by the original linguist and project manager to ensure final approval with full traceability.

Sample Projects and Experience

Sample Projects and Experience

Sesen has supported leading cardiovascular device manufacturers with high-quality translation solutions for global market expansion. Our experience spans Class II and Class III devices, including implantable systems, wearable technologies, and software-integrated platforms. Each project is managed by a dedicated team with deep knowledge of cardiovascular terminology, regional regulations, and multilingual QA workflows.

Sesen translated Instructions for Use (IFUs), technical labeling, and package inserts for a U.S. FDA-approved drug-eluting stent into 22 European languages. The project supported CE marking under the EU MDR and included terminology harmonization, linguist validation, and patient-facing content localization. Sesen also translated the software user interface for a connected remote monitoring platform integrated with the device.

We delivered multilingual translations for an implantable loop recorder and cardiac telemetry system targeting the Japanese, Korean, and Chinese markets. The scope covered clinician guides, surgical setup instructions, and regulatory submissions. Our team implemented client-specific translation memory and glossary tools to maintain consistency across multiple device versions.

Sesen provided full localization of a 3D cardiac mapping software suite used in electrophysiology labs. We translated UI strings, software manuals, training documentation, and labeling content into 12 languages. The project included in-context validation, functional QA, and coordination with the client’s software engineering team to streamline multilingual release.

Our proven track record ensures that Sesen is a trusted partner for cardiovascular device translation at every stage of the product lifecycle.

Intelligent Translation Workflows for Regulated Content

Intelligent Translation Workflows for Regulated Content

Sesen combines human expertise with advanced translation tools to deliver accurate, compliant, and scalable language solutions for cardiovascular medical devices. Our workflow infrastructure is designed to support regulatory rigor, multilingual consistency, and rapid turnaround for global product launches and updates.

We operate on an enterprise-grade, cloud-based TMS that supports collaborative workflows between clients, linguists, and project managers. The platform enables real-time tracking, centralized file management, and role-based access control for enhanced data security and compliance.

Our system leverages client-specific translation memories and multilingual termbases to maintain consistency across documentation sets. All terminology is aligned with product specifications, regulatory language, and standard medical vocabularies such as MedDRA and SNOMED CT.

We offer in-context string translation for embedded software, digital interfaces, and electronic IFUs. This ensures linguistic accuracy within UI constraints and improves user experience across languages, particularly for wearable cardiac monitors and remote diagnostic systems.

For select documentation types such as internal training materials or draft regulatory references, we provide machine translation post-editing (MTPE) performed by qualified linguists. MTPE is used only when appropriate and never for patient-facing or safety-critical content.

Sesen’s technology-integrated approach enables precision, speed, and full regulatory traceability while maintaining the highest standards of linguistic quality.

Global Language Coverage for Cardiovascular Devices

Sesen provides professional medical translation services in over 150 languages to support the global distribution of cardiovascular devices. Our linguists are native speakers with expertise in medical device terminology, regional labeling requirements, and regulatory documentation formats. Each translation is customized to meet the linguistic, cultural, and compliance expectations of the target market.

We support translation for all major language groups relevant to cardiovascular product launches, regulatory submissions, and clinical use:

  • European Languages: French, German, Italian, Spanish, Dutch, Portuguese, Polish, Czech, Hungarian, Greek, and others
  • Asian Languages: Japanese, Chinese (Simplified and Traditional), Korean, Vietnamese, Thai, Indonesian, and more
  • North and South America: Latin American Spanish, Brazilian Portuguese, Canadian French, English (US and UK)
  • Middle Eastern and Central Asian Languages: Arabic, Hebrew, Turkish, Farsi, and Urdu
  • Nordic and Baltic Languages: Swedish, Danish, Norwegian, Finnish, Estonian, Latvian, and Lithuanian
  • Other Key Markets: Russian, Ukrainian, Romanian, Bulgarian, Serbian, and additional Eastern European languages

All translations are aligned with local market expectations and include support for regional formatting, localized measurement units, and government-required terminology.

What Sets Sesen Apart in Cardiovascular Device Translation

What Sets Sesen Apart in Cardiovascular Device Translation

Sesen is a trusted translation provider for some of the world’s leading cardiovascular device manufacturers. Our exclusive focus on life sciences and deep understanding of global regulatory frameworks make us uniquely qualified to support high-risk, multilingual medical content. Whether preparing an IFU for CE marking or localizing software for a wearable cardiac monitor, we deliver precise, compliant translations with speed and consistency.

Sesen translates exclusively for the life sciences sector, including pharmaceuticals, biotechnology, and medical devices. This singular focus allows us to apply therapeutic-area expertise, regulatory precision, and clinical terminology accuracy to every project.

We bring more than language expertise. Our team is well-versed in FDA requirements, EU MDR Annex I, ISO 13485, and other global standards. Every translation is prepared to meet the scrutiny of notified bodies, ethics committees, and regulatory agencies.

Cardiovascular device companies often face tight timelines for market entry, product recalls, and labeling updates. We offer expedited translation workflows without compromising quality, helping clients meet urgent regulatory deadlines.

Sesen supports regulatory affairs, quality, and clinical operations teams with scalable language services that integrate seamlessly into your product lifecycle. From initial submission to post-market surveillance, we provide consistent, validated translations that reduce risk and streamline approvals.

We have translated high-stakes documentation for implantable defibrillators, drug-eluting stents, TAVR systems, and advanced cardiac monitoring platforms. Our clients include top-tier device manufacturers, contract research organizations, and regulatory consultants.

Related Services for Cardiovascular Device Companies

Related Services for Cardiovascular Device Companies

Sesen offers a full range of translation and localization solutions to support the entire medical device lifecycle. Explore related services that complement your cardiovascular device documentation needs:

Let’s Talk About Your Cardiovascular Device Translation Needs

Whether you are preparing regulatory submissions, launching in new markets, or updating labeling for MDR compliance, Sesen is ready to support your multilingual documentation goals. Our team of life sciences experts delivers accurate, audit-ready translations for high-risk cardiovascular products with speed and precision.

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