Translations

Accurate multilingual documentation for regulated markets

Expanding medical devices and digital health products into international markets requires more than word-for-word translation. Product labeling, instructions for use, and software interfaces must accurately reflect regulatory requirements, precise medical terminology, and the context of each target market.

Medxfile provides translation and localization services for life sciences organizations managing multilingual documentation across the product lifecycle. With more than 20 years of experience working with regulated medical device documentation, we support manufacturers bringing products to international markets with documentation that is accurate, consistent, and market-ready.

What We Translate

We support translation and localization of regulated and technical documentation, including:

  • Instructions for Use (IFU)
  • User manuals and quick start guides
  • Software user interfaces and software documentation
  • Product labeling and packaging content
  • Safety information and warnings
  • Technical and engineering documentation
  • Internal procedures and training materials

Medical and Technical Subject Matter Expertise

Accurate translation of regulated documentation requires more than linguistic fluency. Our translators and editors hold backgrounds in life sciences, engineering, and technical communication — supporting precise use of medical terminology and consistent translation of technical content across languages.

This expertise is particularly relevant when translating documentation that must remain aligned with risk management files, regulatory submissions, and product labeling requirements, where terminology inconsistencies can have regulatory consequences.

Structured Translation and Quality Review

Translation projects follow a defined multi-stage workflow designed to support accuracy, consistency, and quality across all target languages:

  1. Content Preparation — Source documentation is reviewed and prepared for translation, including terminology review and project scoping.
  2. Subject-Matter Translation — Translators with relevant technical backgrounds produce the initial translation.
  3. Independent Linguistic Review — A second native-language reviewer checks terminology, clarity, and accuracy against the source.
  4. Proofreading and Quality Control — Final verification confirms consistency across all documentation components.


This process is designed to identify potential ambiguities early and maintain alignment across multilingual documentation.

Software and Digital Health Localization

For software and digital health products, we provide localization services for software user interfaces, embedded system displays, mobile and web applications, and help systems and in-app documentation.

Localization workflows are structured to support software validation and accommodate documentation updates throughout iterative development cycles.

Project Management and Integration

Each project is coordinated by a dedicated project manager responsible for timelines, team communication, and workflow integration. Our teams work within established development environments and are familiar with Agile, Waterfall, Kanban, and Scrum frameworks — allowing translation activities to integrate with your existing product development processes.

Get in touch with us

Whether you are looking for on-site consultants for individual products or complete end-to-end management of your documentation and translation projects, trust us to deliver on time and exceed your expectations.

info@medxfile.com

Europe

352-2028-6968

352-661-745-734

Americas

1-516-217-2778

Middle East

972-524-707-700

Medxfile Careers

Project Manager

Location: Hybrid in Luxembourg
Job Type: Full-time
Job Role: Project Manager
Job Code: MX2411

Job Description

We are seeking a full-time Project Manager with experience in the medical device industry. The candidate will ensure the successful management and completion of translation and localization projects within budget and timeline and within our quality standards. Responsibilities include creating project budget and timelines, delivering projects within agreed budget, and maintaining all project related administration tasks. 

  • Main point of contact for client communications, sales and client services for all project related matters. 
  • Be the bridge between client and production staff and remove bottlenecks or obstacles in the way of successful completion of the project. 
  • Communicate regularly with the General Manager to provide project status and discuss issues affecting the project. 
  • Relevant experience with leading projects for the life sciences sector.
  • A keen attention to detail, professionalism, and ability to manage project timeline is critical.

 

Qualifications, Skills and Experience:

  • Excellent written and verbal English communication skills, other languages would be an asset
  • University Degree
  • Excellent problem solving and analytical skills
  • Independence in carrying out assigned tasks
  • Ability to work under pressure in a fast-paced environment
  • Experienced in project management processes (Waterfall, Agile, Scrum, Kanban)
  • Experience in translation and localization project management would be a strong advantage

 

Please send your resume along with your contact information to jobs@medxfile.com or refer to someone who could be a good fit.

Medxfile Careers

Technical Writer - French to English Translator

Location: 100% Remote (EU time zone)
Job Type: Contract – Part-time
Job Role: Technical Writer
Duration: 3-6 Months
Job Code: MX2403

Job Description

We are seeking a French to English Translator for a contract position with experience in the medical device industry. Our translation team works for the top companies within the life sciences industry with a focus on medical devices. This requires a high level of service, professionalism, and translation quality and care. Your particular language skills and medical device and regulatory affairs will allow you to create high quality client-facing translations that are up to the standards of the client. 

  • Able to understand the meaning and context of medical research reports or any other research related material, and is able to translate into the English language by making sure that original context and meaning is preserved
  • Able to consult, discuss and highlight any content related issues or concerns with subject matter experts and other colleagues in order to understand specialized concepts and translate them appropriately
  • Able to refer to online translation tools for additional assistance with translation, where applicable
  • Able to research, check and accurately confirm statements, numbers, company/ product names and other material in written research submitted (as necessary)
  • Maintain glossaries, translation memory, and style guides
  • Managing projects/deliverables by actively communicating with team members about deadlines and informing all interested parties of deliverable timelines and status
  • Responsible for timely escalation of any issues to your manager and assisting them in resolving issues as well

Please send your resume along with your contact information to jobs@medxfile.com or refer to someone who could be a good fit.

Medxfile Careers

Technical Writer

Location: 100% Remote (EU time zone)
Job Type: Contract – Full-time
Job Role: Technical Writer
Duration: 6 Months
Job Code: MX2409

Job Description

We are seeking a full-time Technical Writer for a contract position with experience in the medical device industry. The candidate will be responsible for writing and editing the flagship user manual and quick guides while adhering to the company style guide. We are seeking a candidate that can work independently to develop the content based on SME interviews, technical specs/drawings, and hands-on exploration.

The Technical Writer will research technical and engineering data (PRDs, SRSs, specifications), including drawings, design and test specifications, product prototypes, and be able to confidently interview SMEs. The candidate will be responsible for the creation of graphical designs and product screenshots (HW/GUI) for product documentation. 

  • Degree or equivalent in a relevant scientific or medical discipline or a related field,
  • Proven experience in technical writing in the medical industry,
  • Good knowledge and understanding of FDA/MDR/MDD medical device labeling requirements and regulations.
  • Relevant experience with writing customer-facing (patient) documentation.
  • A keen attention to detail, professionalism, and ability to manage project timeline is critical.
  • Excellent grammar, editing, and written communication skills are a must.
  • Process-oriented with excellent planning and organizational skills,
  • Strong oral and written communication skills.

Please send your resume along with your contact number to jobs@medxfile.com or refer to someone who could be a good fit.