Who Signs Off When AI Triages an Airworthiness Directive
Agentic AI is entering AD and SB processing in MRO, raising a hard question about audit trails and accountability under FAA and EASA continued airworthiness rules.
Find here all our blog posts tagged with: agentic AI.
The Assurance Gap Agentic AI Exposes Isn't Aviation's Alone
Agentic AI breaks the deterministic testing model behind DO-178C, and the same structural gap is emerging across ISO 42001, EU AI Act, and FDA regimes.
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.
Two Curves, One Decision: Agentic AI's Control Authority Is Outrunning Its Oversight
Industrial operators are handing agentic AI direct control authority faster than monitoring tools can verify it, and buyers need a risk tier to tell the two apart.
Self-Verifying AI Doesn't Mean Self-Qualifying
Agentic AI is moving into aerospace design and engineering tooling, but DO-330 tool qualification still governs whether any of that verification counts.
When the Scientist Is an Agent: Governing AI Before It Reaches the IND
Ono Pharmaceutical's rollout of agentic AI to every discovery scientist exposes a governance gap that sits upstream of any device or wearable regulation.
Agentic AI Is Outrunning Aviation's Security Testing Playbook
Drone swarms and other agentic systems are entering aviation and defense procurement faster than security testing methods built for passive software can assess them.
Aerospace Has Two Kinds of AI Assurance. Agentic Systems Need a Third.
Certification and model health monitoring both fall short of testing whether an agent's decision loop can be manipulated before it acts.
Design Controls Weren't Built for Models That Change
FDA is piloting exceptions rather than rewriting design controls for GenAI devices, leaving compliance leaders to build the continuous verification the rule doesn't require.
Agentic AI in Clinical Trials Isn't Exempt From High-Risk Classification
Agentic AI tools for trial design look administrative, but EU AI Act and MDR overlap rules can pull them into conformity assessment regardless of vendor intent.
The Real AI Device Risk Is Where FDA Doesn't Look Closely
Most AI-enabled devices clear FDA through the least rigorous pathway or avoid device classification entirely, leaving agentic AI's failure modes unexamined.
The Closed-Loop Question: When Industrial AI Agents Get to Act Alone
Zero-miss safety trials and closed-loop agents are pushing plant leaders to decide how much autonomy AI gets inside existing quality and safety systems.
Design Controls Were Built for Outputs, Not Agentic Reasoning
FDA's total product life cycle framework for AI-enabled devices documents data lineage and output correctness, but not the intermediate process failures unique to agentic architectures.
The Inspection Layer's Governance Gap
Deep learning inspection tools are moving into FDA and MDR/IVDR-regulated production lines faster than the validation methods built to certify them.
The Governance Debt Building in Drug Discovery AI
Regulatory frameworks are expanding toward AI in drug development, but the real exposure is a silent-failure risk that neither hype skeptics nor regulators are pricing in yet.
ISO 42001 Gets a Precedent, Not a Verdict
NADEC's ISO 42001 certification gives industrial AI buyers a reference point, but one certificate does not settle whether the standard closes the gap between documented control and operational reality.
