IMDMC's 2016 REG 101 & 102 

Two-Day program, moderated by Professor 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, touching other areas of regualtion along the way. Sign up for just one class, or attend both at a reduced price!

Register Now! 

More Information

Day 1 Agenda 4/21/16

• 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
• Current FDA Initiatives
• Panel Discussion "Linking the Pieces" and Q&A

Day 2 Agenda 5/19/16

• Interactions with FDA
• QSR
• Reimbursement
• Complaint handling/Medical Device Reporting
• Sales & Marketing: Regulatory Aspects
• Recalls and Field Corrections
• Inspsections
• Enforcement
• Other Liability Mechanisms

EVENT SPONSORSHIPS ARE AVAILABLE AT THE FOLLOWING LEVELS

GOLD - $2000 

• Primary recognition at Workshops
• Half page ad in Workshop Workbooks
• 2 free registrations at each session
• Scholarship student from IU Graduate School to spend day with your company representative at REG101

SILVER - $1000

• Secondary recognition at Workshops
• Quarter page ad in Workshop Workbooks
• 1 free registration at each session

BRONZE - $500

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

Sign up to SPONSOR Now!