In this session, we’ll show medical device teams how to bring design controls back under one roof — and keep them audit-ready every day, not just the week before submission.

Today, requirements live in Word, risk sits in Excel, and validation records are scattered across a shared drive no one fully trusts. Design controls quietly fracture. Changes cascade unnoticed. Traceability breaks open between milestones. And when an FDA inspector, Notified Body auditor, or TGA reviewer surfaces the gap, the rework is costly and the schedule damage is real.

You’ll see how Modern Requirements, Copilot4DevOps, and Agents4DevOps work together — natively inside Azure DevOps — to enforce design controls, preserve DHF and Technical Documentation traceability, and maintain continuous audit readiness. Your engineers and quality leads stay accountable for the decisions that matter. AI handles the monitoring, flagging, and generation that used to swallow their week.