Team-NB clarifies CDx changes under IVDR Annex IX 5.2

Team-NB clarifies CDx changes under IVDR Annex IX 5.2

11.11.2025
Regulatory Updates | Precision Medicine & CDx
Performance studies in gene therapy trials: from assay cut-offs to clinical impact

Performance studies in gene therapy trials: from assay cut-offs to clinical impact

31.10.2025
Blog & Insights | IVDs, Precision Medicine & CDx
Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

21.10.2025
Blog & Insights, IVD News | Digital Health & AI, IVDs, Laboratories, Precision Medicine & CDx
MDx CRO at MPP 2025: Aligning Companion Diagnostics and Drug Development under IVDR

MDx CRO at MPP 2025: Aligning Companion Diagnostics and Drug Development under IVDR

20.10.2025
Events & Conferences | Precision Medicine & CDx
MDx CRO at ESMO 2025 (Berlin): Advancing IVDR Transitions & Combined Clinical Trials

MDx CRO at ESMO 2025 (Berlin): Advancing IVDR Transitions & Combined Clinical Trials

20.10.2025
Events & Conferences | IVDs, Laboratories, Precision Medicine & CDx
TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia

TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia

16.10.2025
Blog & Insights, IVD News | IVDs, Precision Medicine & CDx