When
Thursday June 25, 2015 from 8:00 AM to 4:30 PM EDT and Sept. 10, 2015 from 8:00 AM to 4:30 PM EDTAdd to Calendar
Kathy Heuer
Indiana Medical Device Manufacturers Council
260-609-2802
imdmc@imdmc.org
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!
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