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Life Sciences Blog

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Can IVDR Guide Global Market Access for IVDs? | QbD Group

Can IVDR Be Your Global Regulatory Compass for Market Entry?

Regulatory Affairs In Vitro Diagnostics

Jun 4, 2025 4:51:11 PM

The In Vitro Diagnostic Regulation (IVDR) in the EU is widely considered one of the most rigorous re...

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR | QbD Group

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

Regulatory Affairs Clinical In Vitro Diagnostics

Mar 26, 2025 11:20:26 AM

We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Gr...

The Advent of Artificial Intelligence and Machine Learning in Medical Devices - QbD Group

The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Software Solutions & Services Medical Devices

Dec 9, 2022 1:00:00 AM

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the ...