TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory Updates
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
Understanding the MDCG 2023-4 Guidance on Medical Device Software and Hardware Combinations

Understanding the MDCG 2023-4 Guidance on Medical Device Software and Hardware Combinations

20.10.2023
Regulatory Updates | Digital Health & AI
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
Influenza Assays: Risk Classification Under IVDR

Influenza Assays: Risk Classification Under IVDR

27.07.2023
IVD News, Regulatory Updates | IVDs
MDR Transition Period: Updated Q&A Document, Changes & Clarifications

MDR Transition Period: Updated Q&A Document, Changes & Clarifications

20.07.2023
Regulatory Updates | Medical Devices
New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?

New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?

02.06.2023
IVD News, Regulatory Updates | IVDs, Laboratories
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