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Life Sciences Blog

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Bridging the Regulatory Gap: Integrating IVDs into Global Clinical Trials

Bridging the Regulatory Gap: Integrating IVDs into Global Clinical Trials

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR Companion Diagnostics (CDx)

Oct 10, 2025 1:07:42 PM

As global clinical trials grow in scale and complexity, integrating In Vitro Diagnostics (IVDs) into...

IVD Use in EU Clinical Trials: Key Considerations Under the IVDR

IVD Use in EU Clinical Trials: Key Considerations Under the IVDR

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR Companion Diagnostics (CDx)

Oct 10, 2025 12:01:46 PM

The use of in vitro diagnostic (IVD) devices in clinical trials has become increasingly complex unde...

Annex XIV Applications: Common Delays and How to Avoid Them

Annex XIV Applications: Avoid These 5 Common Delays

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR Companion Diagnostics (CDx)

Sep 4, 2025 4:18:50 PM

In vitro diagnostic devices (IVDs) play a critical role in modern healthcare. From disease diagnosis...

The Impact of EU IVDR on Clinical Trials - QbD Group

The Impact of EU IVDR on Clinical Trials

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR Companion Diagnostics (CDx)

Mar 25, 2024 12:30:00 AM

We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...