Find here all our blog posts tagged with: medtech.

Three distinct colored light paths converging on an abstract glowing medical device against a dark background.

Three Regulators, Three Different Bets on AI Medtech

The EU, the US, and China are sequencing AI device oversight in opposite orders, and compliance leaders need to plan for all three.

A human hand and a robotic arm converging toward a single point of light in a clinical setting, symbolizing parallel evaluation of clinicians and AI devices.

The Doctor Test for AI Devices

FDA's move toward clinician-style, ongoing assessment of AI-enabled devices reshapes what counts as durable evidence, ahead of any final guidance.

A robotic surgical arm glowing with fiber-optic light inside a sterile operating theater.

The AI Lifecycle Decision Medtech Can't Wait to Make

J&J's Monarch clearance shows predetermined change control plans already govern AI updates, a lifecycle discipline device makers need now, not after genAI guidance lands.