Verifika
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TMS
MT
MT
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Rapid and reliable localization services for your goals into 50+ languages
Medical Device Translation Services
Medical Device TRANSLATION
Palex is ISO 17100 certified and has been providing medical devices localization services for 19 years. We translate in over 50 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