May 25, 2026 / by Margarita Núñez Estimated read time: 13 minutes
We’ve gathered the most common questions about our medical translation services into this comprehensive FAQ blog article.
Section 1: Certifications & Quality
Q: Is SimulTrans ISO-certified for medical translation?
A: Yes. SimulTrans holds three ISO certifications directly relevant to medical translation services:
- ISO 9001: ensures well-documented processes, consistent execution, and continuous quality improvement.
- ISO 17100: translation-specific standard defining qualified linguist requirements, structured workflows, mandatory second-linguist revision, and comprehensive project management.
- ISO 18587: covers human post-editing of machine translation, the exact process required for EU AI Act Article 50 compliance.
SimulTrans also maintains an Information Security Management System (ISMS) certified to ISO 27001. Copies of annual ISO certificates are available upon request.
Q: What qualifications do SimulTrans' medical translators have?
A: SimulTrans works exclusively with professional linguists who are native speakers of the target language and have a minimum of five years of specialized experience. Many translators hold degrees in medicine, clinical research, or life sciences and are fluent in industry-specific terminology, therapeutic area knowledge, and global regulatory frameworks.
Q: What is a certificate of translation and does SimulTrans provide one?
A: A certificate of translation is a signed declaration verifying that a translation is true, accurate, complete, correct, and performed to the best of the translator's ability and expertise. Many pharmaceutical, medical device, and CRO clients require certificates for regulatory compliance. SimulTrans provides certificates in electronic format free of charge, and can customize them to suit your regulatory submission format.
Q: How does SimulTrans ensure translation quality end-to-end?
A: SimulTrans uses a six-step quality process for every medical project:
- Up-front analysis, materials testing to detect problems before translation begins.
- Translation by native-speaking subject-matter experts with relevant medical qualifications.
- Subject-matter expert review, verifying accurate terminology and industry standards.
- Proofreading by an independent linguist not involved in the initial translation.
- Back translation when required by ethics committees or regulatory authorities.
- Quality Assurance checks, testing of deliverables before they are sent to the client.
Q: How does SimulTrans handle highly technical medical terminology?
A: SimulTrans creates client-specific glossaries and term bases, seeking approval from the client's internal team when necessary. Translation memory ensures consistent terminology across all versions of a document and related projects. Subject-matter expert reviewers confirm that terminology accurately reflects industry standards. Glossaries and term bases are maintained and updated for future product revisions.
Section 2: Regulatory Compliance
Q: Does SimulTrans specialize in EU MDR 2017/745 translation?
A: Yes. SimulTrans specializes in EU MDR 2017/745-compliant translation. SimulTrans accurately translates all manufacturer information that must accompany a medical device, including regulatory documents, labeling, and Instructions for Use (IFUs), into over 100 languages. Both forward and back translations and signed certificates of translation are available.
Q: Does SimulTrans provide IVDR-compliant translations?
A: Yes. SimulTrans is an ISO-certified provider of medical translation and delivers all types of translations and back translations for in vitro diagnostic medical devices (IVDs) using qualified linguists. SimulTrans' certified translations help companies meet EU MDR, IVDR, and FDA requirements.
Q: Does SimulTrans specialize in FDA-compliant translations?
A: Yes. SimulTrans follows a rigorous ISO-driven quality management system. Its certified translations help medical companies meet FDA requirements including 21 CFR Part 801 for medical device labeling. SimulTrans also handles 510(k) submissions, Premarket Approval (PMA) documents, Device Master Records (DMR), Design History Files (DHF), and Risk Management Files (ISO 14971).
Q: How does SimulTrans comply with the EU AI Act for medical translations?
A: Article 50 of the EU AI Act (main compliance deadline: August 2, 2026) requires that AI-generated content either carry a disclosure label or demonstrate comprehensive, documented human oversight. SimulTrans' ISO 18587-certified post-editing process ensures all AI-generated translations undergo rigorous review by qualified medical linguists, satisfying Article 50's requirements and eliminating the need for AI disclosure labels. Documented quality workflows create audit-ready records at every step.
Q: Does SimulTrans help medical device companies comply with GDPR?
A: Yes. SimulTrans translates privacy policies, data processing agreements, and consent forms for medical device and SaMD companies. Many companies operating in the EU provide translations in all 24 EU official languages to ensure content is understandable to end users, as required by the standard regulators. SimulTrans uses human linguistic expertise for all legal and regulatory translation.
Q: Does SimulTrans support compliance with Section 1557 of the Affordable Care Act?
A: Yes. SimulTrans provides translated documents that help patients fully understand their rights and access healthcare services, supporting ACA Section 1557 compliance. All translated documents are reviewed by human linguists to meet the high accuracy standards required by law.
Q: What is linguistic validation, and when is it required?
A: Linguistic validation ensures translated content is not only linguistically accurate but also conceptually equivalent across languages. The process involves forward translation by multiple translators, reconciliation, back translation, cognitive debriefing with native speakers, and final review. It is required for clinical trial instruments, patient-reported outcomes used in regulatory submissions, and informed consent forms.
Section 3: Process and Timelines
Q: What types of medical documentation does SimulTrans translate?
A: SimulTrans translates the full range of medical and life sciences content, including:
- Instructions for Use (IFUs), labeling, and packaging
- Regulatory submissions: 510(k), PMA, DMR, DHF, ISO 14971 risk files
- Clinical trial documents: informed consent forms, case report forms, patient questionnaires
- Pharmacovigilance and periodic safety update reports
- Diagnostic and medical device software user interfaces
- eLearning and training materials
- Technical manuals and service documentation
- Marketing and patient-facing materials
Q: How long does a medical translation project take?
A: Medical translation projects range from three days to three months, depending on word count and team size. Each translator handles approximately 2,000 words per day, and SimulTrans' translators work simultaneously across all target languages, so adding languages does not extend your timeline. A typical project has three translators and two reviewers per language; large projects have used over 100 translators per language. AI-assisted translation with post-editing can accelerate delivery by 40–60%.
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 by an independent linguist who was not involved in the original translation. It helps identify missing words, mistranslations, or ambiguities. Back translation is commonly required for clinical trial materials, patient-reported outcomes, and informed consent forms by ethics committees, review boards, and regulatory authorities. SimulTrans provides back translation into more than 100 languages.
Q: Can SimulTrans manage ongoing updates to translated medical documents?
A: Yes. SimulTrans uses translation memory to store previously approved translations. When a document is revised, only the changed text needs to be re-translated, reducing cost and ensuring version consistency. SimulTrans integrates with content management systems through secure connectors to automate ongoing workflows, and the SimulTracker portal keeps projects organized for team collaboration.
Q: Does SimulTrans provide SaMD and SiMD software localization?
A: Yes. SimulTrans provides medical software localization for both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Services include terminology extraction, user interface translation, UI and controls adjustment, reformatting, and thorough testing using automated LQA processes combined with human testers.
Q: Who are SimulTrans' typical medical translation clients?
A: SimulTrans serves medical device manufacturers, pharmaceutical and biotech companies, contract research organizations (CROs), and in vitro diagnostic (IVD) manufacturers. Notable clients include, Medtronic, Signat Health, GE Healthcare, and Bausch + Lomb. Please contact us if you require specific company names in your sector.
Section 4: Cost and File Formats
Q: How much does medical translation cost?
A: Costs vary by language, typically corresponding to the cost of living in target countries. For example, translation into Simplified Chinese costs approximately one-third of translation into Swedish. Four main factors affect price:
- Word volume: the total number of words to be translated
- Number of languages: each language is a separate cost
- Translation method: human translation vs. AI-assisted translation with post-editing
- Additional services: back translation, software localization, testing, and desktop publishing
Get a free quote for your next medical translation project.
Q: What file formats does SimulTrans accept for medical documents?
A: SimulTrans works with any file format, including Word, Excel, JSON, HTML, XML, DITA, InDesign, Figma, PowerPoint, and more. The team manages translation, back translation, and multilingual formatting for all medical and regulatory document types, from 510(k) submissions and PMA documents to IFUs and labeling under 21 CFR 801.
Section 5: Technology and AI
Q: Can SimulTrans use machine translation for medical content, and is it safe?
A: Yes, SimulTrans can use AI-assisted machine translation for medical content, but it is always combined with ISO 18587-certified human post-editing by qualified medical linguists. Raw machine translation without human review is not appropriate for compliance-sensitive medical content. SimulTrans can assess whether your content is suitable for AI-assisted translation. Contact SimulTrans to request a Machine Translation Suitability Report.
Q: What is the difference between translation and localization for medical devices?
A: Translation converts content from one language to another with linguistic accuracy. Localization goes further, adapting content for cultural appropriateness, local regulatory requirements, measurement units, date formats, software functionality, and user interface conventions in each target market. For medical devices, localization ensures IFUs, labeling, and software interfaces are fully appropriate and functional for end users and regulatory authorities in each country.
Q: How does SimulTrans handle post-market surveillance documentation?
A: SimulTrans translates all post-market surveillance documentation required by EU MDR and FDA, including adverse event reports, field safety notices, periodic safety update reports, CAPA reports, standard operating procedures, and audit documentation. SimulTrans uses translation memory to store previously approved translations. When a document is revised, only the changed text needs to be re-translated, reducing cost and ensuring version consistency. SimulTrans' ISO-certified quality management system creates the audit trail required by regulators throughout the entire device lifecycle.
Section 6: Security and Confidentiality
Q: How does SimulTrans protect the confidentiality of sensitive clinical and medical data?
A: SimulTrans maintains an Information Security Management System (ISMS) in accordance with the global ISO 27001 standard. All employees receive comprehensive cybersecurity training. Strict non-disclosure agreements (NDAs) and encryption protocols protect confidential medical data and intellectual property.
Q: How long has SimulTrans been providing medical translation services?
A: SimulTrans was founded in 1984 and established a dedicated medical translation division in the 1990s. With over 40 years of experience and decades of specialized medical expertise, SimulTrans serves medical device manufacturers, pharmaceutical companies, biotechnology firms, and CROs worldwide. The company maintains a 97% customer satisfaction rate as of 2025.
