TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory Updates
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
IVDR Lab Readiness: Step-by-Step Transition Checklist

IVDR Lab Readiness: Step-by-Step Transition Checklist

28.09.2025
Blog & Insights, Regulatory Updates | IVDs, Laboratories
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
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
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