Join RAPS Boston for an in-depth session unpacking the real world regulatory playbook for AI-enabled wearable devices, from first submission to post-market evolution. Learn from industry leaders Robert Michalik and Tahir Rizvi as they reveal how AI fits within design controls, accelerates development, and reshapes clinical strategy. Gain actionable insights on PCCPs, FDA engagement, and risk mitigation to streamline 510(k) clearance. Leave with a stronger understanding of the AI regulatory landscape and practical insights to support informed decision-making.