The Medtech Regulatory Intelligence Virtual Summit will take place November 13-15. The event will be held from 10:00am-1:00pm U.S. EST with each day focusing on specific aspects of medtech regulation.

Monday, November 13 – U.S. Market – Current Regulatory Focus

• Market Access and Postmarket Surveillance of AI Systems
• Preparing for Global Alignment in in Quality Management System Regulation: ISO 13485
• Unique Device Identifiers: The Move Toward UDI-DI and the FDA’s Current Focus in Compliance Efforts
• Recall Readiness: Best Practices, Required Activities and Challenges Associated with a Product Recall

Tuesday, November 14 – Global Regulatory Intelligence

• EU MDR: Developing a Sustainable Post-market Surveillance Program
• What’s Happening in the UK and Switzerland
• Reaching the Asian Market: Certification Challenges and Considerations for China and Japan
• Regulatory Advocacy: Effective Commenting and Working with Industry Associations

Wednesday, November 15 – Streamlining Regulatory Operations

• Post Market Literature Surveillance: Medical Safety at the Forefront, Best Practices and Case Study
• Complaint Management & Assessment
• Are you Inspection Ready? How to Create an Inspection-ready Team and Prepare for Remote Assessments.

“As global regulatory demands increase, regulatory professionals are tasked with managing growing workloads and surveiling and meeting a varying array of global regulatory requirements,” says Inga Hansen, program director and editor of MedTech Intelligence. “This program is designed to provide insight into the current and coming global regulatory landscape and provide strategies and best practices for ensuring compliance.”

The event offers two registration options: Individual ($99) or Enterprise License ($395), which allows companies to include their entire regulatory team under one registration. Learn more about the event here.