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.

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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.