Second Medical Device Regulatory, Reimbursement and Compliance Congress Announces Keynote Faculty and Special Sessions
  • Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse, and Reimbursement
  • Classes Held in Harvard University's Annenberg Hall and Harvard Faculty Club
  • Congress Hotel: The Inn at Harvard, Cambridge, MA
  • March 28 - 30, 2007
Phone: 800-684-4549

CAMBRIDGE, MA USA -- HEALTHCARE UPDATE NEWS SERVICE™ -- DECEMBER 22, 2006: The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress (Device Congress),, will be held on the campus of Harvard University March 28 - 30, 2007. The Device Congress is sponsored by Compliance-Alliance, Harvard Health Policy Review, Health Affairs, Medical Education Collaborative and a variety of leading publications.

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the Medical Device Congress to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Medical Device Regulatoion, Reimbursement, and Compliance issues."


Click here to review an at-a-glance overview of the Device Congress.


The Device Congress Featured Faculty includes:

Susan Alpert, Ph.D., MD
Senior Vice President and Chief Quality, Regulatory Officer, Medtronic, Former Director, Office of Device Evaluation, Food and Drug Adminstration, Minneapolis, MN
John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
Jennifer Bragg, Esq.
King & Spalding, Former Assistant Chief Counsel for Enforcement, Food and Drug Administration, Washington, DC
Peter Claude
Partner, PricewaterhouseCoopers LLP, Florham Park, NJ
Richard DeRisio
Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc., San Antonio, TX
Denise Dion
Senior Regulatory Consultant. EduQuest, Formerly with FDA's Office of Regulatory Affairs
Marc Farley
Executive Director of Health Care Compliance, Johnson & Johnson, Inc., New Brunswick, NJ
William T. Fitzgerald, Esq.
Vice President, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX
David R. Jones
Director Quality Assurance, Regulatory Affairs Consumer Healthcare Solutions Phillips Medical Systems, Andover MA
Kenneth E. Imler, MBA, Six Sigma Black Belt
Senior Vice President, Regulatory Affairs and Quality Assurance, Arrow International, Author, Get it Right: A Guide to Strategic Quality Systems, Reading, PA
Cecilia Kimberlin, Ph.D.
Group Vice President of Quality Assurance, Regulatory, Compliance, and Medical, Medical Products Group, Abbott Laboratories
Stephanie Mensh
Vice President, Reimbursement Policy,, Former Vice President, Payment and Policy, AdvaMed
Robert H. O'Holla, MBA
Vice President of Regulatory Affairs, Medical Devices and Diagnostics Group, Johnson & Johnson, New Brunswick, NJ
Daniel P. Olivier
Certified Software Solutions, Inc., President, San Diego, CA
Paul J. Silver
Managing Director, Huron Consulting Group, Atlanta, GA
Nancy Singer, Esq.
President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
Christopher L. White, Esq.
Executive Vice President, General Counsel, and Secretary, AdvaMed, Washington, DC

  • Preconference I: Implementing International Codes of Conduct
  • Preconference II: Understanding Private Payers and Maximizing Private Payer Reimbursement Strategies
  • Preconference III: After the Inspection: Managing FDA Enforcement Actions
  • CDRH's Regulatory Agenda for 2006 - 2007
  • CMS Priorities for 2006 - 2007: What Device Innovators Should Know about Medicare Regulation?
  • Fraud and Abuse: Lesson Learned From Government Prosecutions in 2005 - 2006
  • A Dash of FDA, a Pinch of CMS and What Do You Get?
  • International Harmonization: Reality or Fantasy
  • Using Management Controls to Translate Policies and Principles into Practice?
  • Implementing Effective Supplier Management Programs
  • Creating an Effective Internal Audit Program
  • Collecting Useful Design Verification and Validation Information
  • Assessing Complaints and Service Reports
  • Implementing an Effective CAPA System
  • Setting Up a Defensible System to Make Reports of Removals and Corrections
  • Defending Your Decision for Class I, II or III Recalls
  • The OIG: Getting Companies to Comply with the Law
  • AdvaMed Efforts to Promote Regulatory Compliance
  • The Regulatory Authority for Off-Label Promotion and Recent Enforcement Actions
  • Understanding Where FDA Draws the Line
  • Challenging the Government's Authority
  • The Alphabet Soup of Clinical Quality Standards: What's Important? What Isn't?
  • Coping with Reimbursement Rules and Challenges: How Device Companies Deploy their Resources
  • Coding Trends: How to Get Your Device through the Coding Maze?
  • Managing Payment Policy for Your Acute Care Products under Cut-backs in Hospital and ASC Payments
  • Managing Payment Policy for Your Post-Acute Care Products across Systems and through Competitive Bidding
  • How to Convince the Medical Director Why Your Product is Special
  • Making the Case for the Value of Your Device with Practice-Based Evidence



For sponsorship and exhibit information go to or contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, or at


Register online at, call 800-684-4549, email or write:

    Device Congress Office
    3291 West Wilson Road
    Pahrump, NV 89048