IMDMC's 2017 REG 101 & 102 

Two-Day workshop 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 regulatory information through interactive teaching methods, from experts in each field. Attendees will take a hypothetical device from pathways to market, through clinical trials, promotion and advertising and then work through recalls, QSR & MDR reporting and inspections, touching other areas of regulation along the way. Sign up for just one class, or attend both at a reduced price!

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More Information

Day 1 Agenda 5/17/17 - 8:00 AM - 5:00 PM

• Breakfast will be available from 7:30 - 8:00
• FDA Overview
• Regulatory Intelligence
• Clinical Trials/IDE's
• Pathways to Market 510K Requirements
• Pathways to Market PMA Requirements
• Other Submissions & Special Issues
• Pre-Market QSR
• Labeling, Advertising & Promotion
• Panel Discussion "Linking the Pieces" and Q&A

Day 2 Agenda 5/24/17 - 8:00 AM - 5:00 PM

• Breakfast will be available from 7:30 - 8:00
• Interactions with FDA
• Post-Market QSR
• Complaint handling/Medical Device Reporting
• Sales & Marketing: Regulatory Aspects
• Recalls and Field Corrections
• Inspsections
• Enforcement
• Other Liability Mechanisms
• Panel Discusion "Linking the pieces" and Q&A

EVENT SPONSORSHIPS ARE AVAILABLE AT THE FOLLOWING LEVELS

GOLD - $1000 

• Primary recognition at Workshops
• Half page ad in Workshop Workbooks
• 2 free registrations 

SILVER - $500

• Secondary recognition at Workshops
• Quarter page ad in Workshop Workbooks

BRONZE - $250

• Tertiary recognition at Workshops
• Logo and one sentence descriptor in Workshop Workbooks

Sign up to SPONSOR Now!