Presented to:

Great Plain Chapter ACRP
Omaha, NE
October 25, 2007

Copyright© - P. Below Consulting, Inc. 2009
All rights reserved.

Presentation

• Ensuring Quality in Medical Device Clinical Trials (Powerpoint 760 KB)
  

References

• “Device Clinical Trials and More…”, Michael Marcarelli (presented to MassMEDIC on May 18, 2007) (www.massmedic.com/docs/cdrh07.ppt)
• “Building Quality into Device Clinical Trials, Part 1,” Michael E. Marcarelli et al., MDDI (Jul 2006): pg. 60 (www.devicelink.com/mddi/archive/06/07/011.html)
• “Building Quality into Device Clinical Trials, Part 2,” Michael E. Marcarelli et al., MDDI (Oct 2006): pg. 56 (www.devicelink.com/mddi/archive/06/10/015.html)
• “Five Habits of Highly Effective Device Sponsors,” Michael Marcarelli, The Monitor (Feb 2007): pg. 83
• “Improving Clinical Compliance in the Medical Device Industry,” Barry Sall, MDDI, March 2006 (www.devicelink.com/mddi/archive/06/03/016.html)
• “An Interview with Michael Marcarelli: Improvements Seen in the Oversight of Medical Device Research,” Susan Rockwell, The Monitor (Apr 2006): pg. 62
• CDRH BIMO Program Website (www.fda.gov/cdrh/comp/bimo.html)
• FDA BIMO Compliance Program Manuals (www.fda.gov/ora/cpgm/default.htm#bimo)