Second Medical Device Regulatory and Compliance Congress Sessions Announced
  • 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 -- OCTOBER 17, 2006: The Second Annual Medical Device Regulatory 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 Regulatory and Compliance issues."


John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, 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
William T. Fitzgerald, Esq.
Vice President, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX
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
David R. Jones
Director of Worldwide Quality and Regulatory for Patient Monitoring, Philips Medical Systems, and Former Director of Global Quality Information Systems, Worldwide Software Quality Assurance and Software Compliance Strategies, Bausch & Lomb, Andover, MA
Paul J. Silver
National Leader, Health Sciences, Investigative and Dispute Services, Ernst & Young LLP, 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

  • Complying with International Regulatory Requirements for Pre and Post Marketing Activities
  • Implementing International Codes of Conduct
  • Obtaining Reimbursement from Private Payers
  • Business Writing: How to Avoid Liability in Legal and Regulatory Proceedings
  • 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

Individuals interested in making presentation proposals for the Medical Device Regulatory and Compliance Congress may submit a proposal by clicking here. Proposal should be submitted on or before Friday, October 20, 2006 in order to be considered.




For sponsorship and exhibit information 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
    7790 Barberry Ave.
    Yucca Valley CA USA 92284