IVDR compliance

Getting Ahead of the IVDR Tsunami

The transition to the In Vitro Diagnostic Regulation (IVDR) marks a pivotal moment for the in vitro diagnostics (IVD) industry. This new regulatory framework, implemented in the European Union, has been introduced to address the evolving landscape of diagnostic technologies and patient safety. Compared to the 20 year old In Vitro Diagnostic Directive (IVDD), the IVDR has ushered in stricter and more standardized regulations to ensure the safety, efficacy, and quality of IVD devices. It hasn’t been an easy transition.

Download White Paper

Related Posts

ai medical translation

AI-Powered Translation Solutions: Transform Your Life Sciences Localization with Clinical Precision

ai medical translation

What a Medical Translation Company Should Deliver Beyond “Accurate Translation”

ai medical translation

Pharmaceutical Marketing Translation: What Brands Must Get Right

ai medical translation

A Practical Guide to Medical Device Labeling Translation

ai medical translation

Clinical Trial Translation Services: Ensuring Accuracy from Protocol to Publication

ai medical translation

ePRO Translation: Why Accurate Patient-Reported Data Depends on It

Quality AI Translation

Case Study

Quality AI Translation

Quality In The Age of AI: A Language Scientific Webinar

In this exclusive fireside chat, Language Scientific dives into how AI is transforming translation quality across the life sciences. This conversation features insights from Ashley Mondello, VP of Operations, whose decade of experience leading life science localization, AI integration, and global delivery operations offers a rare look at how quality truly works in the age of AI.