Medical Device Complaints, MDRs, and Reports

May 07 – 08, 2013 — Sheraton Crystal City, Arlington, VA

Overview |  Agenda |  Speakers |  Logistics |  Fees


How do you implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDR's, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises, and discussion of pre-submitted questions, expert industry faculty explore these issues in practical terms.

MTLI wants you to know the elements of an effective complaint management system, FDA's expectation about trending complaints from non-US markets, how to ensure that your electronic records database handling complaints complies with 21 CFR Part 11, how to investigate complaints to determine if they are MDR's, the dos and don'ts when informing FDA of a product problem, FDA's involvement in health hazard evaluation and classification, and more...

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Steven Binion, Director, Corporate Regulatory, BD
Deborah Deutsch, Director, Quality Compliance, Edwards Lifesciences
David Dills, Regulatory & Compliance Consultant
Michael Gaba, Partner, Holland & Knight
Mike Heyl, Partner, Hogan Lovells
Lina Kontos, Associate, Hogan Lovells
Dick Roy, Sr. MDR Manager, Medtronic Cardiac Rhythm Disease Management
Dana Yurach, Quality Assurance Manager II, Aptiv Solutions

Hotel & Meeting Logistics

Sheraton Crystal City
1800 Jefferson Davis Highway
Arlington, VA  22202

Reservations:  1-888-627-8209 (Reference AdvaMed when making reservations)
or online at:

Room rate:  $259.00  
Rate available 3 days prior/post meeting based on hotel availability
Hotel cut-off date for reservations:  4/15/13

Registration Fees

AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Sponsor Registration: $0.00

Please contact for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)