SOLUTIONS

Localization
AI for Localization
Machine Translation
Language Services
Multimedia

Legal
IP
Litigation
Compliance

Marketing
Transcreation
Performance Linguistics
Paid Media
Multilingual SEO
Marketing Localization

Medical Device
Labeling
IVDR

Clinical
Clinical Translation
Linguistic Validation
Pharmacovigilance

Additional Solutions
E-learning

Interpretation
Product Testing

AI Training Data

Ready to elevate your global strategy?

Contact us to explore how our expertise in translation, localization, and AI data
training can drive precise and scalable solutions for your business.

Get in touch
- Localization
- Legal
- Marketing
- Medical Device
- Clinical
- Additional Solutions
Devices and IOTs
Pharmaceutical
Clinical Research
Organization
Law Firms
Corporate Offices
Technology
Manufacturing
Entertainment

Our AI-enabled Service Delivery Platform gives you fast, easy and accurate translations

Communication today happens at the speed of AI. You need to localize content quickly and easily to accelerate your time to market and drive stronger business outcomes.

Get in Touch
Opal

Designed to tackle the growing challenges in data quality, trust, and origin.

Legal Studio
Patent Filing
Litigation
Compliance

Adapt Studio
Powered by Opal

AI Training Data
Continuing a Heritage of Innovation

Since our founding in 1997, we have been at the forefront of applying advanced technology to deliver the highest quality translations quickly, efficiently and at scale. Through constant investment in these technologies and our early adoption of AI, Welocalize has earned a reputation for delivering innovative solutions.

Join the Community - We're Hiring

About Us

Company
Executive Team
Careers
Locations
News Room

Insights

Blogs
White Papers
Case Studies
Guides
Podcasts
Webinars

IVDR Compliance – Precision, Accuracy & Regulatory Confidence

The In Vitro Diagnostic Regulation (IVDR) is reshaping the landscape for medical device manufacturers, requiring higher transparency, stricter labeling regulations, and precise multilingual documentation. Non-compliance isn’t an option

Bring Your Diagnostic Products to Market. With Confidence.

Welocalize ensures your IVD devices meet EU IVDR requirements with accurate, compliant, and culturally adapted translations. With our AI-driven linguistic validation, regulatory expertise, and scalable multilingual solutions, you can bring your diagnostic products to market with confidence.

What Is IVDR? Why Does It Matter?

The EU In Vitro Diagnostic Regulation (IVDR 2017/746) replaces IVDD, introducing stricter requirements for:
Multilingual labeling & IFUs (Instructions for Use)
Increased scrutiny of diagnostic claims
UDI (Unique Device Identification) compliance
Post-market surveillance & traceability

By May 2025, all IVD devices in the EU must fully comply. Are you ready?

Ensure Global Compliance with IVDR

Achieve compliance across international markets with our end-to-end services—built to help you adapt to evolving regulations while maintaining full control and visibility over your content.