Find here all our blog posts tagged with: AI SaMD.

Abstract layered forms contrasting a fixed structure with a fluid, shifting one to evoke static documentation versus adaptive systems.

MedTech Diligence Now Has to Read Change Plans, Not Just Technical Files

AI-enabled devices are adding predetermined change control plans to MDR/IVDR technical files, and buyers evaluating MedTech targets need to diligence both.

A luminous bridge connecting two distinct rock formations, symbolizing a unified regulatory pathway between separate compliance regimes.

The PCCP Window Before the AI Act Deadline Closes

IMDRF's new PCCP principles and the EU AI Act's delayed medtech deadline create a narrow window to build one change control architecture instead of two.