Find here all our blog posts tagged with: life sciences compliance.

Abstract glowing branching pathways symbolizing decision drift in automated clinical trial monitoring.

Clinical Trials Are Running Agentic AI Faster Than Regulators Can Define It

Agentic AI now handles protocol deviation detection and trial monitoring, but no current framework tests for decision drift across autonomous runs.

A multi-layered glass hourglass with sand suspended between tinted panes, symbolizing a regulatory grace period built from stacked compliance layers.

The Extended Clock Is Not a Reprieve

The EU AI Act's delayed enforcement dates for medical device AI give sponsors more runway, but only if they use it to align MDR/IVDR and AI Act evidence now.

A line of light divides a clinical space, symbolizing the boundary between regulated and unregulated AI tools.

The Boundary FDA Won't Police

FDA's 2026 clinical decision support guidance draws a line around what counts as a regulated device, leaving compliance teams to make that call themselves.

A wearable health device shown split between a clinical, regulated half and a consumer wellness half, illustrating the FDA's shifting classification line.

FDA Just Moved the Wellness Line. That Is a Liability Decision, Not a Compliance Break

FDA's broadened wellness classification for AI-enabled wearables forces life sciences leaders to choose their liability posture, not just their regulatory burden.