When

September 11, 2019 from 8:00 AM to 5:00 PM EDT 

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Where 

The Montage
8580 Allison Pointe Boulevard
Indianapolis, IN 46250  


 
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Contact

Anne Hathaway 
Indiana Medical Device Manufacturers Council 
833-245-8828 
imdmc@imdmc.org 
 

IMDMC's 2019 Post Market Workshop 

Wednesday, September 11, 2019 from 8 a.m.- 5 p.m.

This workshop is designed for regulatory professionals and lawyers in the medical device industry to give them insight into FDA regulations. This program has been developed to provide 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. PREMARKET WORKSHOP ATTENDANCE NOT REQUIRED TO ATTEND POST MARKET WORKSHOP.

IMDMC Members: $250

Non-members: $300

*Workshop pending approval for CLE credit to legal professionals. 

Agenda 

7:30-8:00 a.m.              Registration & Breakfast
8:00-8:15 a.m.              Welcome                                                           
8:15-9:00 a.m.              Post-market QSR                                           
9:00-9:45 a.m.              Complaint Handling & MDR                           
9:45-10:00 a.m.            Break                                                                      
10:00-10:45 a.m.          Recalls & Field Corrections                             
10:45-11:30 a.m.          Sales & Marketing Regulatory Aspects          
11:30 a.m.-12:00 p.m.  Lunch                                                                     
12:00-12:45 p.m.          Inspections                                                     
12:45-1:30 p.m.            Other Liability Mechanism                              
1:30-1:45 p.m.              Break
1:45-2:30 p.m.              Enforcement                                                     
2:30-3:15 p.m.              Risk Management                                      
3:15-4:00 p.m.              FDA Recalls & Current Trends                                    
4:00-4:45 p.m.              Trademarks & FDA Name Approval    

4:45-5:00 p.m.              Conclusion                                                       

EVENT SPONSORSHIPS ARE AVAILABLE AT THE FOLLOWING LEVELS

GOLD - $1000 

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

SILVER - $500

  • Recognition at Workshops
  • Quarter page ad in Workshop Workbooks

BRONZE - $250

  • Recognition at Workshops
  • Logo and one sentence descriptor in Workshop Workbooks