TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory Updates
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
Clinical Evaluation of Orphan Devices: Navigating MDCG 2024-10

Clinical Evaluation of Orphan Devices: Navigating MDCG 2024-10
02.07.2024
Blog & Insights, Regulatory Updates | Medical Devices
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
Understanding MDCG 2021-6 Rev. 1: A Comprehensive Guide for Clinical Investigations under EU MDR

Understanding MDCG 2021-6 Rev. 1: A Comprehensive Guide for Clinical Investigations under EU MDR
16.03.2024
Blog & Insights, Regulatory Updates | Medical Devices
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
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