agilityIRL Upcoming Events
AI Governance in MedTech: Practical Models, Industry Case Studies, and Evaluating the Right Approach
November 3, 2026 | Time 10am - 11am Central | Link To Sign Up | Webinar with Medical Alley
AI adoption is accelerating. Is your governance keeping up?
As AI becomes part of medical device software, product development, and quality workflows, organizations face pressing questions:
- Who approves its use?
- How are outputs validated?
- Who is accountable when an algorithm fails or drifts?
Join agilityIRL and Medical Alley for an interactive panel discussion exploring how MedTech organizations can build practical AI oversight that supports innovation, quality, and accountability. Through industry case studies and real-world organizational models, we’ll compare centralized, cross-functional, and team-level approaches. We will examine how AI governance can fit within your existing Quality Management System (QMS).
What you’ll learn:
- How MedTech organizations structure AI decision-making, approvals, and escalation pathways.
- How to evaluate governance models based on your organization’s culture, size, risk profile, and development needs.
- How oversight differs for AI embedded in medical device software versus tools used in internal design, testing, and quality workflows.
- Where AI governance connects with ISO 14971 risk management, ISO 13485 quality processes, and evolving FDA and EU expectations.
You’ll leave with an evaluation checklist, practical insights for integrating AI oversight into your QMS, and diagnostic questions to assess how your teams use AI today.
Designed for MedTech leaders and professionals in engineering, product development, quality, and regulatory affairs.