GessNet has launched the Safe and Effective AI for Medical Products (SEAI) initiative, a structured effort to define how artificial intelligence can be applied responsibly within regulated medical-product development.
The initiative focuses on the practical governance questions that arise as AI-assisted tools are introduced into design, risk-management, and evidence-generation workflows: defined intended use, verifiable evidence, accountable oversight, and a documented decision trail for AI-assisted outputs.
SEAI will inform how GessNet advises clients on AI adoption and how AI-assisted capabilities are introduced into QMSpace, GessNet's digital platform for regulated development.