MedTech, IVD & Regulatory Insights
Monthly regulatory digest & free resources, we read and analyse the regulations so you do not have to.
- Weekly articles with updates and resources
- Monthly newsletter with highlights
- Webinar invitations & event updates
- Full archive access, all blog posts & white papers
Regulatory Intelligence from 50+ Specialists
Our content is written by a multidisciplinary team of over 50 professionals, former national competent authority reviewers, notified body auditors, clinical research associates, and biomedical engineers, each with hands-on experience navigating the MDR and IVDR.
Every article, white paper, and resource we publish is grounded in the work we do daily for manufacturers: writing clinical evaluation reports, designing clinical investigations, compiling technical documentation, and supporting conformity assessments across Europe.
This is not recycled regulatory commentary. It is practical, manufacturer-focused material built from real project experience, the same expertise we apply when working with our clients.
FDA Regulation of In Vitro Diagnostic Devices: The Complete Guide for US Market Entry
ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility
Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs
ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation
Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know
How to Run a CDx Performance Study Alongside a Drug Trial: Insights From 20+ Projects
Case Study: How MDx Enabled Argen’s Successful Transition to MDR CE Marking for Dental Alloys
Companion Diagnostic Clinical Trial Case Study
IVDR CE marking NGS: MDx Case Study with Fulgent
IVDR Transition for Precision Medicine: How MDx CRO Enabled a Seamless Portfolio Upgrade
