USDM sponsored event

AI in Regulatory Affairs at RAPS Convergence 2026

Meet USDM at RAPS Convergence 2026 to explore high-impact regulatory AI use cases and the Defensible AI framework built for life sciences.

UDI registration and EUDAMED submission visual for global medical device regulatory compliance.

USDM's Participation

Title: Understanding Global UDI Requirements & Effectively Managing UDI Data & Submissions

Date: Wednesday, Sept. 16, 10:45 - 11:10 a.m.

Register for the session

Title: Managing Global UDI Compliance Ahead of EUDAMED Implementation: Implications for Regulatory Information Management

Date: Wednesday, Sept. 16, 4:30 - 5:30 p.m.

Register for the session

At RAPS Convergence 2026, USDM is focused on practical AI in regulatory affairs: where AI can improve readiness, consistency, traceability, and inspection response without creating uncontrolled compliance risk.

Visit USDM in Booth #401 during the conference to discuss AI governance, UDI reconciliation, regulatory data quality, and inspection-ready AI programs.

USDM applies Defensible AI, a governance-first standard for regulated environments, so AI systems are explainable, auditable, validated, and overseen in a way an inspector or board member can understand.

Connect with USDM at RAPS

AI regulatory focus areas

AI can support submission readiness and QC, labeling management, regulatory commitments management, and inspection readiness when the operating model is governed from the start.

The product data and UDI record is the foundation: a single traceable source of truth helps teams catch record errors, incomplete attributes, compliance drift, and recall scope problems before they become inspection findings.

USDM’s Defensible AI framework helps regulated teams make AI explainable, auditable, and controlled through governance architecture, validation frameworks, cost resilience, and organizational literacy.

Connect with USDM at RAPS

Use this form to connect with USDM about AI in regulatory affairs, Defensible AI, product data governance, UDI reconciliation, or inspection-ready AI programs.

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