EUDAMED Mandatory Timelines for MDR and IVDR

EUDAMED Mandatory Timelines for MDR and IVDR

27.11.2025
Regulatory Updates | IVDs, Medical Devices
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 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
MDx to Present ESMO 2025 Poster on IVDR CE Marking for Large Germline NGS Panels

MDx to Present ESMO 2025 Poster on IVDR CE Marking for Large Germline NGS Panels

07.10.2025
Events & Conferences | Digital Health & AI, IVDs, Laboratories, Precision Medicine & CDx