Medical Device TRANSLATION

Palex is ISO 17100 certified and has been providing medical devices localization services for 19 years. We translate in over 80 languages helping the world's leading medical devices companies enter the global market.

WHAT WE DO

We Translate All Medical Device Documents!

Medical devices translation is one of our major focus areas. For many years we have been working on such types of medicl devices content as design documents, manufacturing guides, operational instructions, compliance declaration, marketing, IFU, customer training materials, and more.

02.

Medical Device Design Dossier

04.

Medical Device Directives Translation

06.

Assessment Procedures

05.

Declaration of Conformity

03.

CE Marking Technical File

01.

Medical Device Marketing Materials

08.

Operation Procedures

10.

Medical Device Training Manuals

12.

Labels

11.

Device Labels Translation

09.

Instructions for Use (IFU) Translation

07.

In Vitro Diagnostic Device Labeling

14.

Regulatory Submission Dossier

16.

Health Technology Assessment

18.

Instructions for Use

17.

Package Inserts

15.

Quality System Document

13.

Manuals

20.

Patents

19.

Technical Document

Industries

Palex provides ISO certified document translation services for leading companies in pharmaceutical, medical devices, healthcare, biotech, and CRO industries. We translate a variety of medical documents, including IFUs (information for use), informed patient consent documents, medical device user manuals, clinical protocols, healthcare training manuals, and much more.

Life Sciences Translations

The process

02.

Project execution

03.

Post localization QA

Translation adhering to ISO 17100 (4 eyes principle)

Linguistic QA

Formal QA with our versatile Verifika tool: Glossary adherence, numerics, country standards, punctuation etc.

Documents layout (DTP) in target language followed by cosmetic validation

Project preparation

01.

Client requirements analysis

Source files preparation, project scope, cost and timelines estimate

Thorough content analysis in order to select best matching linguists

Team kick-off: all linguists are onboarded and linguistic moderator is appointed to ensure smooth and consistent communication within the team

Term extraction, glossary creation

Reference pack preparation

Subject matter expertise (SME) in order to ensure the target documents are ready to go

Delivery to the client

In-country review

Finalization

Extraction and preparation of all relevant translatable content

Estimation of word counts, costs and turnaround times

Term glossary and style guide development

Creation of a company-specific translation memory (TM) to store all translated content