Navigating IVDR for NGS Assays: Challenges and Solutions with MDx CRO

Navigating IVDR for NGS Assays: Challenges and Solutions with MDx CRO

28.09.2025
Blog & Insights | IVDs, Precision Medicine & CDx
COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics

COMBINE Programme: Streamlining EU Combined Studies for Medicines, Devices, and Diagnostics

17.12.2024
Blog & Insights, IVD News, Regulatory Updates | Precision Medicine & CDx
MDCG 2020-16 Rev.3: IVDR Classification Rules

MDCG 2020-16 Rev.3: IVDR Classification Rules

09.07.2024
Regulatory Updates | IVDs, Precision Medicine & CDx
IVDR Performance Studies and the ISO 20916:2024 Revision

IVDR Performance Studies and the ISO 20916:2024 Revision

02.04.2024
IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
MDx: Your Dedicated CRO for IVD Clinical Studies in the EU

MDx: Your Dedicated CRO for IVD Clinical Studies in the EU

24.08.2023
Blog & Insights | IVDs, Precision Medicine & CDx