TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory Updates
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
IVDR CE marking NGS: MDx Case Study with Fulgent

IVDR CE marking NGS: MDx Case Study with Fulgent

07.10.2025
Blog & Insights, Case studies, IVD News | Digital Health & AI, IVDs, Laboratories, 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
EU Reference Laboratories under IVDR: What Class D Manufacturers Must Know

EU Reference Laboratories under IVDR: What Class D Manufacturers Must Know

06.09.2024
IVD News | IVDs
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
FDA Laboratory Developed Tests (LDTs) Regulation

FDA Laboratory Developed Tests (LDTs) Regulation

04.10.2023
IVD News, Regulatory Updates | IVDs, Laboratories
Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

24.08.2023
IVD News, Regulatory Updates | IVDs
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