Medical device translation services
Clear, compliant and audit-ready multilingual communication for medical device manufacturers and health technology companies. Our medical device translation services support Instructions for Use (IFUs), labels, software interfaces and regulatory submission documentation – helping localisation managers and regulatory affairs teams meet FDA, MDR and global regulatory requirements without delaying product launches or compromising patient safety.
350+
current clients
30+
years of experience
120+
languages
Medical device translation services for regulated content and critical use cases
Medical device manufacturers operate within a broader regulated life sciences environment. Our medical device translation services form part of our wider medical translation services, supporting pharmaceutical, clinical research and health technology companies with compliant, patient-safe multilingual communication.
IFUs and labelling
Clear, precise IFUs are essential for safe device use and regulatory compliance. We translate printed and electronic IFUs, symbols, warnings and packaging content in line with EU MDR, IVDR and local language requirements, ensuring consistency across product variants and markets.
Regulatory and technical documentation
We support the translation of technical files, clinical evaluation reports (CERs), post-market surveillance (PMS) documentation and other regulatory materials used in submissions and audits. Our workflows prioritise traceability, terminology control and version management.
Software and device interfaces
For connected devices and software-driven products, usability and safety depend on accurate localisation. We translate user interfaces, error messages and embedded strings with in-context review to reduce the risk of user error and support regulatory expectations around usability engineering.
Service, maintenance and training materials
Accurate servicing and maintenance documentation support device performance and patient safety long after launch. We translate service manuals, training materials and internal documentation to ensure consistent knowledge transfer across global teams and partners.
What medical device content do you need translated?
- IFUs and eIFUs
- Device labelling, symbols and packaging content
- Technical documentation
- CERs and PMS documentation
- Regulatory submission materials for EU, US and global markets
- Software, firmware and user interfaces
- Installation and service manuals
- Clinical, service and sales training materials
- Marketing and product communication
Ensure compliance and quality through our medical device translation services
Medical and regulatory terminology expertise
Our linguists are trained in life sciences and device-specific domains, working with validated termbases to ensure consistent use of approved terminology across IFUs, submissions and supporting materials. This reduces rework during regulatory review and helps maintain alignment between translated content, source documentation and approved labelling.
Audit-ready, compliant workflows
Our translation and review processes are designed for regulated environments. Every project follows documented workflows aligned with ISO 17100, with clear traceability from source files to final delivery. We support your internal quality and regulatory processes by maintaining version control, review records and full audit trails – giving you confidence during notified body reviews, inspections and internal audits.
Confidentiality and data security
We protect your information through secure file transfer and encrypted storage, GDPR-compliant handling of personal and clinical data, controlled access to translation memories and terminology resources, and clear data retention and sanitisation policies. Your documentation remains protected throughout the localisation process, without introducing unnecessary compliance risk.
Responsible use of machine translation
Machine translation can support efficiency for certain types of medical device content, such as repetitive technical sections or standardised documentation. Where appropriate, we combine carefully configured AI-powered translation with expert human post-editing by subject-matter linguists. Safety-critical, regulatory and patient-facing content is always handled with full human translation and review.
Read our blog: Understanding MDR language requirements for medical devices
EU MDR has significantly raised expectations around the accuracy, consistency and availability of multilingual medical device documentation. Language requirements are now a core component of regulatory compliance, audit readiness and patient safety.
This blog post breaks down what manufacturers and distributors need to know about translating IFUs, labels, regulatory documentation and clinical information for EU markets. Updated to reflect the current MDR environment, it covers:
- Mandatory language requirements under Article 41 and Annex II
- Terminology consistency expectations linked to EUDAMED
- The implications for IFUs, labelling, clinical documentation and PMS
- How translation quality impacts regulatory approval and patient safety
For localisation and regulatory teams managing multilingual submissions across multiple markets, understanding these requirements is essential.
Get in touch
Find out how our medical device translation services can support your regulatory, localisation and product teams – from early development through global launch and post-market surveillance.
Frequently asked questions about medical device translation services
Medical device translation services focus on the accurate translation of regulated, technical and patient-facing content used throughout the medical device lifecycle. This includes IFUs, labelling, software interfaces and regulatory documentation, all of which must meet strict compliance and usability requirements.
We work with linguists experienced in EU MDR and IVDR requirements and follow documented, auditable workflows. Terminology control, version management and traceability are central to our approach, supporting smoother reviews by notified bodies.
Yes. We support parallel launches across multiple regions and languages, coordinating terminology, schedules and review cycles to reduce delays and maintain consistency.
We adapt to your localisation environment, tools and approval processes wherever possible, ensuring minimal disruption to established regulatory and quality workflows.
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