REG 101 & 102 

Two-Day program, moderated by Ralph Hall, designed to give a person new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been developed to provide practical examples and information through interactive teaching methods. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising and then work through reimbursements and recalls, QSR & MDR reporting and inspections, and touching other areas of regualtion along the way. Sign up for just one class, or attend both!

Register Now! 

More Information

Day 1 Agenda 6/25/15

• FDA Overview
• Regulatory Intelligence
• Pathways to Market (Classification, 5109(k) req., PMA req)
• Clinical Trials/IDE's
• Labeling, advertising & promotion
• Special Issues
• Pre-Market QSR

Day 2 Agenda 9/10/15

• QSR
• MDR reporting
• Recalls & related topics
• Reimbursement
• Inspections
• Enforcement
• Other Liability Mechanisms