TypeAllBlog & InsightsCase studiesEvents & ConferencesIVD NewsRegulatory UpdatesWhitepapers
SectorAllDigital Health & AIIVDsLaboratoriesMedical DevicesPrecision Medicine & CDx
How to Choose a Notified Body for Medical Devices and IVDs

How to Choose a Notified Body for Medical Devices and IVDs
27.08.2026
Blog & Insights, Regulatory Updates | IVDs, Medical Devices
Medical Device Industry Trends 2026: Where the Market Is Growing, and Why the Forecasts Disagree

Medical Device Industry Trends 2026: Where the Market Is Growing, and Why the Forecasts Disagree
23.08.2026
Blog & Insights | Medical Devices
FDA Human Factors Guidance 2026: What the Final Guidance Means for Your Submission

FDA Human Factors Guidance 2026: What the Final Guidance Means for Your Submission
04.06.2026
Regulatory Updates | Medical Devices
FDA Regulation of In Vitro Diagnostic Devices: The Complete Guide for US Market Entry

FDA Regulation of In Vitro Diagnostic Devices: The Complete Guide for US Market Entry
04.06.2026
Regulatory Updates | IVDs, Precision Medicine & CDx
Scientific Validity Report (SVR) Under EU IVDR: From Literature Review to Defensible Scientific Argument

Scientific Validity Report (SVR) Under EU IVDR: From Literature Review to Defensible Scientific Argument
01.06.2026
IVD News | IVDs
MDCG 2021-24 Rev.1: What Changed in EU MDR Device Classification (April 2026)

MDCG 2021-24 Rev.1: What Changed in EU MDR Device Classification (April 2026)
26.05.2026
Regulatory Updates | Medical Devices
Request the Precision Medicine Services Pack​
Gain access to MDx’s Precision Medicine Services Pack—detailing our capabilities in clinical research, regulatory strategy, and companion diagnostics. Learn how we support pharma, CDx, and advanced therapy developers across the clinical and regulatory lifecycle.