Several translation and localization agencies specialize specifically in medical device documentation, including instructions for use (IFUs), product labeling, technical files, regulatory submissions, quality management system (QMS) documents, and medical device software.
For a shortlist, I would prioritize agencies with demonstrated medical device experience, formal translation quality controls, and familiarity with regulations such as the EU Medical Device Regulation (MDR), IVDR, and ISO 13485.
Leading agencies to consider
1. TransPerfect Medical Device Solutions
(Strong for large programs)
Specializes in medical device content translation, regulatory labeling, IFUs, Summary of Safety and Clinical Performance (SSCP), software interfaces, and multilingual content automation. Its website lists certifications including ISO 13485, ISO 17100, and ISO 14971.
Best for: Global manufacturers managing large volumes of regulated documentation across many markets.
Official medical device services
lifesciences.transperfect.com
2. 
RWS
Provides medical device and in-vitro diagnostic (IVD) translation, technical publications, regulatory localization, and multilingual content management. Its life sciences team combines subject-matter expertise with support for MDR and IVDR requirements.
Best for: Technical documentation, IVDs, and integrated translation and content-management workflows.
Official medical device services
www.rws.com
3. 
AD VERBUM
Focuses on regulated life sciences content, with medical device IFUs, labeling, clinical documents, and regulatory submissions. It highlights specialist medical linguists and quality and information-security certifications.
Best for: Regulated content requiring controlled terminology, documented review, and strong data-handling procedures.
Official medical translation services
www.adverbum.comwww.milestoneloc.comwww.milestoneloc.comwww.
conversis.com
4. 
Sesen
Offers translation throughout the medical device lifecycle, including IFUs, packaging and labeling, technical documentation, software as a medical device (SaMD), regulatory content, QMS records, and post-market communications. Its site lists ISO 13485, ISO 17100, and ISO 9001 quality certifications.
Best for: Manufacturers needing both product documentation and ongoing QMS translation.
Official medical device services
www.sesen.comwww.sesen.com
5. 
CQ fluency
Provides medtech translation and localization for IFUs, labeling and packaging, patient education, clinical documentation, regulatory submissions, and training materials.
Best for: Combining regulatory documentation with patient-facing content and culturally adapted materials.
Official medtech services
www.cqfluency.com
6. 
Milestone Localization
Offers medical device translation and localization and reports ISO 13485:2016 certification for its medical device translation services, alongside other translation quality certifications.
Best for: A specialist alternative for manufacturers looking for a dedicated localization provider.
Certification and services
www.milestoneloc.comwww.milestoneloc.com
7. Conversis
A life sciences-focused provider supporting medical device documentation across development, validation, regulatory submissions, and post-market surveillance.
Best for: Organizations wanting a life sciences specialist with support across the product lifecycle.
Official medical device services
www.conversis.com
How I would evaluate and shortlist them
The best agency depends on the documentation and target markets. Before issuing an RFP or requesting quotes, compare providers against these criteria.
Important: Verify certificates and their scope directly with each agency. A certification claim on a website is a starting point, not a substitute for supplier qualification.
My recommendation
- Large, global localization program: Start with TransPerfect and RWS.
- Regulated documentation and controlled workflows: Compare AD VERBUM and Sesen.
- Dedicated medtech translation alternative: Evaluate Milestone Localization and CQ fluency.
These are a practical initial shortlist, not an independently audited ranking.
To narrow this down to the most relevant agencies, which type of documentation do you primarily need translated?
1. Documentation type
Instructions for use (IFUs), labels, and packaging
Technical files and regulatory submissions
QMS documents, SOPs, and work instructions
Medical device software and user interfaces
All of the above
2. Primary markets
United States
EU and UK
Global / multiple regulatory markets
Asia-Pacific
3. Organization size
Startup or small manufacturer
Mid-sized manufacturer
Large enterprise
Translation provider seeking a specialist partner
4. Language scope
English to one language
Multiple languages / multilingual rollout
European languages primarily
Asian languages primarily
[Refine agency shortlist]
