Medical device documentation translation

2. Sesen

A focused life-sciences provider covering the device lifecycle, from clinical and regulatory documentation to IFUs, labels, software as a medical device (SaMD), and post-market communications. It advertises ISO 13485, ISO 17100, and ISO 9001 credentials, terminology management, and professional human review.www.sesen.com

Best for: A specialist partner for regulated documentation across the product lifecycle.

Medical-device translation services

3. Milestone Localization

Provides life-sciences and technical translation, with published ISO 13485, ISO 17100, and ISO 9001 certifications. The agency reports supporting medical-device manufacturers with EU MDR documentation and multilingual IFUs.www.milestoneloc.com

Best for: Manufacturers needing a combination of translation, technical documentation, and multilingual production.

Official website

4. The Translation Company

A US-based provider that advertises medical-device translation experience since 2005. Its scope includes IFUs, labeling, UDI content, software interfaces, technical files, risk-management documents, and regulatory submissions. It lists ISO 9001 and ISO 17100 standards for its processes.thetranslationcompany.com

Best for: US manufacturers seeking a dedicated point of contact for documentation and international market expansion.

Medical-device translation services

5. GTS Translation Services

Particularly relevant for instructions for use (IFUs) and directions for use (DFUs). Its published services include second-linguist review, certificates of accuracy, terminology-sensitive translation, and document layout support in more than 100 languages.www.gts-translation.com

Best for: IFU translation, multilingual manuals, formatting, and documentation updates.

Medical-device IFU services

6. AD VERBUM

Offers medical-device, clinical, and regulatory translation with specialist linguists and editors. Its published certifications include ISO 13485, ISO 17100, and information-security standards, making it worth considering when confidentiality and formal quality controls are priorities.www.adverbum.com

Best for: Regulated life-sciences documentation and quality-focused multilingual workflows.

Medical and life-sciences services

What I would verify before selecting an agency

For medical-device documentation, ask each candidate to provide:

• Quality credentials: Current certificates and their scope, particularly ISO 13485 and ISO 17100.
• Independent linguistic review: A documented review process appropriate to safety-critical content.
• Regulatory experience: Relevant examples involving EU MDR/IVDR, FDA submissions, or your target markets.
• Terminology and change control: Glossaries, translation memories, revision tracking, and consistency across IFUs, labels, and software.
• Confidentiality and security: Appropriate controls for technical files, unpublished product information, and clinical data.

Certifications and regulatory experience should be verified directly with the agency; a translation supplier does not itself guarantee regulatory acceptance.

Let me narrow this to the best fit

One question: What type of medical-device documentation do you primarily need translated?

1. Documentation type

IFUs, labels, packaging, and manuals

Regulatory submissions and technical files

Device software, UI, and SaMD localization

Clinical, quality-system, and risk-management documents

A complete documentation portfolio

2. Target languages

English to European languages

English to Asian languages

Multiple languages / global rollout

One specific language pair

3. Main selection priority

Regulatory expertise and quality assurance

Cost and turnaround time

Software localization and automation

Long-term partnership and terminology management

4. Preferred agency size

Large global provider

Mid-sized specialist agency

Open to either

[Find the best-fit agencies]

A local option

If being able to work with a Puget Sound-area provider matters, Dynamic Language in Seattle is worth contacting. Its listed capabilities include medical/technical translation and localization, with ISO 13485, ISO 17100, ISO 9001, ISO 27001 and ISO 18587 processes/certifications. For regulated device documentation, I would still ask them to provide the specific certification scope and relevant medical-device references before selecting them.

What I would put in the RFP

For this type of project, ask each provider to demonstrate:

• ISO 13485:2016 and ISO 17100:2015 certification, including the scope of certification.
• Experience with IFUs, operator/service manuals, labeling, technical files, risk-management documentation and regulatory submissions.
• Experience with your specific markets—e.g. FDA, EU MDR/IVDR, Health Canada, UKCA, PMDA, etc.
• A device-specific terminology database/glossary and translation memory.
• Independent linguistic review rather than translation-only delivery.
• Regulatory/certificate-of-accuracy documentation where required.
• Multilingual desktop publishing, preserving tables, warnings, symbols, figures and pagination.
• Controlled handling of document revisions and change tracking.
• Information security/confidentiality appropriate for unreleased device documentation.
• Their policy on machine translation/AI—particularly whether regulated content always receives qualified human review.
• References from manufacturers with devices of comparable complexity and regulatory class.

One important distinction: ISO 13485 certification of the translation provider is useful evidence of a controlled medical-device quality environment, but it doesn't by itself establish that a particular translation meets every regulatory or notified-body requirement. The exact workflow and language requirements should be specified in your supplier qualification process.

If you tell me (1) the target countries/languages, (2) device type/class, (3) approximate page/word volume, and (4) whether you need IFUs only or the full technical/regulatory documentation, I can narrow this to a 3–5 vendor shortlist and compare their capabilities, certifications, geographic coverage, and likely fit.