Article
The European Commission has confirmed full functionality of EUDAMED’s first four modules, with mandatory use beginning 28 May 2026. What … Read more
Article
Understanding EU and U.S. regulatory considerations for post-market advertising and promotion of IVDs is essential to remain in … Read more
Blog
AMDM IVD Fall Focus Meeting 2025: From Policy to Practice in Diagnostic Regulation. As global diagnostic regulation continues to advance, … Read more
Article
To help you better navigate MedTech trials, our experts developed the MedTech Clinical Trial Readiness eBook.
… Read more
Article
Government Shutdown 2025: What It Means for FDA Operations and the Diagnostics Industry
… Read more
Blog
Your Strategic Roadmap for Successful Seasonal Influenza IVD Clinical Trials. Every week counts, and missteps in site startup, patient … Read more
Article
Bill Trembley, our Senior Vice President and Chief Technology Officer, was invited to serve on Medrio’s Early Adopter … Read more
Article
IVD Insights from MedTech Summit: Turning Regulatory Complexity into Strategic Advantage
… Read more
