Solutions Circle 2: Compliance Amidst Uncertainties for Medical Devices

Description Medical device compliance is increasingly challenged by regulatory change, geopolitical developments, and the impact of the AI hype on workforce, skills, and organizational priorities. In the U.S., FDA's Quality Management System Regulation became effective on February 2, 2026, aligning Part 820 more closely with ISO 13485, while in the EU companies must continue navigating the MDR alongside the European Commission's December 16, 2025 proposal to simplify and update the MDR/IVDR framework.

This Solution Circle is designed as a highly interactive exchange. Participants will actively share experiences, discuss real-world challenges, and work together on practical solutions for maintaining compliance in a shifting environment shaped by changing regulatory expectations, global instability, resource pressure, and new ways of working influenced by AI.

By the end of the session, attendees will have gained practical insights from peers and identified risk-based approaches to strengthen compliance amid uncertainty.