December 1, 2025 / by Margarita Núñez Estimated read time: 18 minutes
As medical device companies expand into international markets to capture growth, professional translation services have become crucial for ensuring regulatory compliance, facilitating market access, and maintaining patient safety.
The medical device industry is experiencing unprecedented growth and transformation. According to recent industry analysis, the global medical device market is projected to reach $678.88 billion in 2025, expanding at a compound annual growth rate of 6%. So, this sector will be confronting multiple pressing issues that directly impact translation requirements:
- Evolving Global Regulatory Frameworks
- AI-Driven Device Regulations and Software as Medical Devices (SaMD)
- Post-Market Surveillance and Quality Management Requirements
- Cybersecurity and Data Privacy Compliance
- International Market Entry and Diversification
1. Evolving Global Regulatory Frameworks
Regulatory bodies worldwide are modernizing their frameworks to accommodate technological innovations. The European Union's Medical Device Regulation (MDR) now requires more stringent clinical evidence and quality management practices. Medical device companies must translate all regulatory submission documents into the language of each governing body where approval is sought.
In the United States, the FDA continues to maintain rigorous standards for medical device approvals. Meanwhile, emerging markets such as China, India, Argentina, and South Korea are implementing new regulatory frameworks that require comprehensive translated documentation. Around the world, more and more countries require instructions for use for medical products to be translated into native languages.
SimulTrans Solution: SimulTrans language solutions help medical device companies achieve compliance with evolving regulatory frameworks. With 40 years of experience in the medical translation industry, SimulTrans has established medical translation division specialists who understand the nuances of global regulatory processes. Our ISO 9001, ISO 17100, and ISO 18587 certifications ensure that our translations meet the rigorous standards required by regulatory authorities worldwide. As one satisfied medical device client shared:
“We work with many translation services because of contractual agreements with our clients. When we get to choose the translation vendor, we always choose SimulTrans because of the quality of the work and the project management.” —Signant Health
Read our guide to selecting the best translation partner for Contract Research Organizations (CROs) in our blog article: CRO: Selecting your Translation Partner.
2. AI-Driven Device Regulations and Software as Medical Devices (SaMD)
Artificial intelligence and machine learning technologies are revolutionizing medical diagnostics and treatment. AI-powered surgical robots, predictive analysis systems, and diagnostic imaging tools require specialized documentation that explains complex algorithms and data processing to both regulatory bodies and end users.
Software as a Medical Device presents unique translation challenges. User interfaces, technical specifications, risk assessments, and clinical validation documentation must be accurately translated while maintaining technical precision. Any ambiguity or mistranslation could lead to regulatory rejection or, worse, patient safety risks.
SimulTrans Solution: SimulTrans language solutions help SaMD companies meet regulatory guidelines with accurate translations of medical software. We leverage a defined ISO17100-certified process to accurately translate technical medical content, including software documentation and user interfaces. Our engineering and testing team ensures that your software will function properly in target countries, and our publishers deliver multilingual IFUs and patent manuals that meet regulatory guidelines. This is what our customers say about SimulTrans' responsiveness:
Responsiveness and support from SimulTrans was excellent — it made a real difference in keeping the project moving smoothly and finishing within the deadline. —Cumulus Neuroscience
Learn more about our comprehensive approach in our blog article: 7 Steps to a Successful Medical Diagnostic Translation Project.
3. Post-Market Surveillance and Quality Management Requirements
Continuous monitoring through post-market surveillance is vital for identifying device harms and hazards promptly. Medical device manufacturers must translate adverse event reports, field safety notices, periodic safety update reports, and quality management documentation across all markets where devices are distributed.
Regulatory bodies increasingly require manufacturers to demonstrate robust quality management systems throughout the entire device lifecycle. This necessitates translating standard operating procedures, corrective and preventive action (CAPA) reports, and audit documentation.
SimulTrans Solution: SimulTrans helps medical device companies adhere to device lifecycle quality requirements with ISO-certified translation processes. Our ISO-certified quality management system enables us to meet the rigorous standards of the medical industry. We provide end-to-end services, including independent linguistic reviews and certificates of translation. When requested, translations can be back-translated by independent linguists to verify 100% accuracy. Our project managers, with years of localization experience, create detailed project plans and maintain proactive communication to ensure on-time delivery. These are the three things that clients like most about SimulTrans:
They are reliable, very flexible and proactive! —AliveCor
Download our 20-Point Medical Translation Checklist to ensure your quality management documentation is off to a good start.
4. Cybersecurity and Data Privacy Compliance
Wearable medical devices, telemedicine platforms, and connected diagnostic equipment create new cybersecurity vulnerabilities. Regulatory frameworks now address Bluetooth communication security, data encryption standards, and patient information protection. Companies must translate privacy policies, security protocols, and incident response procedures while ensuring legal compliance across jurisdictions.
The European Union's General Data Protection Regulation (GDPR), while it does not mandate that individuals receive information in their own language, does mention that the information must be "understandable" to the target audience. Enforcement actions have shown that regulators interpret "understandable" to mean in the user's native language when necessary. So, many medical device companies operating in the EU have opted to provide translated privacy notices, data processing agreements, and consent forms in all 24 EU official languages.
SimulTrans Solution: SimulTrans helps medical device and SaMD companies achieve compliance with GDPR with customized medical translation and localization solutions. Understanding that poor translations in regulated industries can lead to compliance violations, SimulTrans emphasizes the importance of human expertise in legal and regulatory translation. Our project managers are always praised for their willingness to go the extra mile to deliver the project on time.
SimulTrans is always bending over backwards to assist us. We always have some strange (and often time-consuming requests), but they are always willing to help us get what we need in the timeframe that we need. —Azenta Life Sciences
Read our blog article on The Importance of Translation Quality in Regulated Industries to understand the compliance risks of inadequate translation.
5. International Market Entry and Diversification
Major medical device companies are recognizing growth potential in markets outside their own. According to industry projections, China's medical device market is expected to reach $63.6 billion. However, each market presents unique linguistic, cultural, and regulatory challenges.
For instance, instructions for use (IFUs), labeling, packaging, and training materials content must be localized for each target market. Medical professionals and patients need to understand device functionality in their native language to ensure effective and safe use.
SimulTrans Solution: SimulTrans enables medical businesses to enter new markets with high-quality translated content that is culturally appropriate for each target market. We translate into more than 100 languages with a team of professional life science translators who are native speakers with medical subject-matter expertise. Our professional human translators bring cultural awareness and linguistic proficiency to navigate specialized terminology and industry-specific medical jargon.
This is what our medical customers value the most:
For me, what I value the most is the confidence the SimulTrans' project manager gives to the clients. Her work inspires trust, and her timing is always on point. To me, she is the best professional. —Bausch + Lomb SA
Download our Life Sciences Case Study to see how we help a client with clinical studies for different customers, to overcome specific challenges such as terminology management, translation memories, and client-specific terminology, for each language.
Why Choose SimulTrans for Medical Device Translation
- Four Decades of Excellence: Founded in 1984, SimulTrans, a privately owned company, has established itself as a trusted partner for leading life science companies, maintaining a 97% customer satisfaction rate.
- ISO Certifications: Our ISO 9001, ISO 17100, and ISO 18587 certifications demonstrate our commitment to quality, proven processes, and continuous improvement.
- Medical Expertise: Our translators are full-time professionals with relevant degrees and extensive experience in medical devices, veterinary, life sciences, and pharmaceutical sectors.
- Comprehensive Services: We provide end-to-end solutions for the medical industry, including linguistic reviews, back translation, certificates of translation, desktop publishing, marketing, website translation, and software localization.
Partner with Industry Leaders
SimulTrans understands the unique challenges facing medical device manufacturers. Our experienced medical translation team is ready to help you navigate complex regulatory requirements, accelerate international market entry, and ensure patient safety through accurate, culturally appropriate translations.
Visit our Medical Translation Services page to learn more about how SimulTrans can support your global expansion.
Frequently Asked Questions (FAQ)
Q: What types of medical documentation does SimulTrans translate?
A: SimulTrans can translate all types of medical documentation, from instructions for use (IFUs), labeling, packaging, regulatory submissions, clinical trial documents, risk assessments, software user interfaces, diagnostics software, training materials, e-learning training modules, to technical manuals into more than 100 languages.
Q: How long does a medical translation project typically take?
A: Turnaround depends on the scope of the project, the total word count, and team size. Each translator usually translates approximately 2,000 + words per day. Our translators work simultaneously, so the number of target languages does not impact your timeline. We can accommodate almost any timeline by scaling our translation team and testers to meet your deadline.
Q: What ISO certifications does SimulTrans hold?
A: SimulTrans holds three key ISO certifications: ISO 9001 (quality management standard), ISO 17100 (translation industry-specific standard), and ISO 18587 (post-editing of machine translation). These certifications ensure we follow well-documented processes consistently and deliver high-quality translations.
Q: Does SimulTrans provide certificates of translation for regulatory compliance?
A: Yes. SimulTrans provides signed certificates of translation (in electronic format) that verify translations are true, accurate, complete, correct, and performed to the best of the translators' ability and expertise. Many of our pharmaceutical, medical device, and CRO clients require these certificates for regulatory compliance. We can customize a certificate to suit your submission requirements format.
Q: What is back translation, and when is it required?
A: Back translation involves translating content from the target language back into the source language to verify accuracy. It is completed independently by linguists who were not involved in the initial translation and do not have access to the original source material. Back translation helps identify missing words, mistranslations, or ambiguities. Some review boards and ethics committees require back translations for patient-facing clinical trial materials. SimulTrans offers back translation services to medical device customers into more than 100 languages.
Q: How does SimulTrans ensure translation quality?
A: SimulTrans employs a comprehensive quality process including: (1) up-front analysis and materials testing to detect problems before the translation project starts, (2) translation by human native-speaking subject-matter experts with relevant medical qualifications per industry (3) subject-matter expert review to ensure accurate terminology, (4) proofreading by independent linguists, (5) back translation when required, and (6) Quality Assurance checks and testing of deliverables before they are sent to the client.
Q: Can SimulTrans translate medical device software and user interfaces?
A: Yes. SimulTrans provides software localization services, including terminology extraction, user interface translation, UI and controls adjustments, reforming, and thorough UI testing using a combination of the latest automated LQA processes and human testers. Our engineers and testers ensure your software will function properly in each target country.
Q: How does SimulTrans handle highly technical medical terminology?
A: Our translators hold relevant degrees and have extensive experience translating medical content in specialized fields. We create glossaries of key terms and seek approval from the client's internal team if necessary. We leverage translation memory for consistency, and conduct subject-matter expert reviews to ensure terminology accurately reflects industry customs and expectations. Then we keep those glossaries and term bases updated with any changes for future product updates.
Q: What is the cost structure for medical translation services?
A: Costs vary by language, typically corresponding to the cost of living in target countries. For example, translation into Simplified Chinese is approximately one-third the cost of translation into Swedish. Four factors play the biggest roles in the cost: volume of words, number of languages, translation method and quality (human v. machine translation and post-editing), and number of services requested (translation, back translation, software localization, testing, multilingual desktop publishing, etc. )
Q: How long has SimulTrans been providing medical translation services?
A: SimulTrans established a dedicated medical translation division of specialized translators, reviewers, and project managers in the 1990s to address the increasing demand for translated content from clients in the life sciences industries. With 40 years in business since our founding in 1984, we have deep expertise in medical device, pharmaceutical, and clinical trial translation.
Q: Does SimulTrans offer AI machine translation with human post-editing for medical content?
A: Yes. SimulTrans can assess whether your medical content is suitable for either AI-generated translation or neural machine translation, and what level of human post-editing effort would be necessary to achieve the desired quality output. We follow ISO 18587 standards and customize neural machine translation engines for your specific content. Professional medical post-editors then review and refine the translations to ensure they meet publishable quality standards.
Q: What makes SimulTrans different from other translation providers?
A: SimulTrans combines 40 years of experience, global locations, ISO certifications, a medical subject-matter expert team, a 97% customer satisfaction rate, and experienced project managers who provide hands-on support. We understand the unique compliance needs of the medical device industry, including global regulatory processes. Our flexible approach, customized language solutions, and deep industry knowledge make us the preferred translation partner for leading life science companies.
About SimulTrans
SimulTrans is a language solution provider. Headquartered in Mountain View, California, with offices in Boston, Dublin, Bonn, Madrid, and Tokyo, SimulTrans serves clients worldwide with professional translation and localization services in more than 100 languages.
Contact SimulTrans today. Visit www.simultrans.com/medical-translation to learn more about our medical device translation services or request a free quote.
