Navigating the IVDR CDx Certification Pathway

Navigating the IVDR CDx Certification Pathway

03.02.2026
Blog & Insights, IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026

ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026

02.02.2026
IVD News, Regulatory Updates | IVDs, Precision Medicine & CDx
IVD Clinical Trials: The Do’s and Don’ts

IVD Clinical Trials: The Do’s and Don’ts

26.01.2026
Blog & Insights, IVD News | IVDs
Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

21.10.2025
Blog & Insights, IVD News | Digital Health & AI, IVDs, Laboratories, Precision Medicine & CDx
TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia

TGA guidance (Oct 2025): IVD Companion Diagnostics (CDx) Requirements in Australia

16.10.2025
Blog & Insights, IVD News | IVDs, Precision 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