Here is some information about our speakers for the Educational Forum on Medical Device Reporting, Complaints, and Recalls, Corrections, and Removals. Their presentations are available in the Agenda.

Al Alonso Al Alonso represents the Regulatory Affairs Professionals Society (RAPS) in FMDIC. He is a medical device Quality Management System and Regulatory consultant. Al worked for DJO Surgical, an orthopedic implant manufacturer from 2003 to 2011 as the VP Quality Assurance and Regulatory Affairs. Prior to that, Al worked 23 years with Carbomedics, Inc., a manufacturer and marketer of implantable cardiovascular devices, as the Vice-President of Quality Assurance, Clinical/Regulatory Affairs and Vice-President of Quality Management. Al has a Bachelor of Science degree in Chemistry from The University of Texas at Austin.
Dr. John C. Criscione Dr. John C. Criscione received his B.S. in Applied Physics from Purdue University in 1991 and his M.D. and Ph.D. from The Johns Hopkins University in 1999. He received post-doctoral training at The Johns Hopkins University and the University of California in San Diego. John is an Associate Professor with the Department of Biomedical Engineering at Texas A&M University and a Charter Fellow of The Michael E. DeBakey Institute of Comparative Cardiovascular Science and Biomedical Devices. He has numerous awards in research, teaching, and service. John studies how mechanics — the study of force and motion in matter — applies to the biology of the heart and how to utilize such knowledge to obtain better clinical outcomes. In addition to inventing, prototyping, testing, and designing medical devices, he researches and teaches topics related to regulatory strategy and entreprenuership.
Scott Eden Scott Eden is the Senior Director Quality and Regulatory at HealthTronics, a wholly owned subsidiary of Endo Pharmaceuticals. He is a Regulatory and Quality Systems professional with experience in Quality Remediation, Supply Chain Management, Quality, Compliance, and Regulatory Management. In Scott’s role at Endo/ HealthTronics, he is responsible for providing strategic direction, oversight and leadership in the development and implementation of best-in-class quality systems, regulatory strategy and continuous improvement. Prior to his employment with HealthTronics, Scott played a global role at Zimmer Orthopedics, where he was responsible for leading the development and implementation of Zimmer’s Global Supplier Quality Management System and Global Quality Systems for Corrective and Preventive Actions (CAPAs).  Before his employment with Zimmer, Scott worked for Smith & Nephew as Group Manager, Quality Systems and Compliance.  Prior to that, Scott worked for Synthes where he also held a variety of Regulatory and Compliance Management positions.
David C. Furr David C. Furr, MS, is an independent industry consultant at FDC Services, LLC.  David has over 30 years of global experience working in the biologics, pharmaceutical, and medical device industries.   He works with executive management and QA/RA staff at several healthcare industry companies in the fields of Quality Assurance/Compliance, Regulatory Affairs, and Clinical Research.  Prior to going into full time consulting in January 2001, David was a Director of QA/RA at Boston Scientific, and a Director Compliance/International Regulatory at Zimmer Orthopedics.  In addition to his consulting, from 2008-2010 he served as Sr. VP of Global QA/RA/Clinical for Ascension Orthopedics inAustin,TX.  His MS degree is in Quality Assurance and Regulatory Affairs; from the Temple University School of Pharmacy.  He also holds a BS degree in Biology fromTexasStateUniversity.  David has written several US and international regulatory submissions, articles for sterilization science and regulatory publications, worked extensively with global regulatory agencies and manufacturers.  He has been a team leader in major compliance remediation projects, helping to deal with warning letters, import holds and other compliance challenges.  He has also participated in the development of industry standards, and has been a presenter/moderator for several industry events.
Graham N. Giesen Graham N. Giesen is a Supervisory Investigator in the FDA Dallas District Office Investigations Branch. He is a Level 2 Certified Medical Device Investigator and most recently served as Investigator for the FDA Seattle District Office. Graham also conducted foreign medical device inspections. Prior to FDA, Graham worked as an Imaging Services Technician specializing in advanced diagnostic imaging systems, including X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI) for a multi-site hospital in Portland, Oregon. Graham is a Certified Radiology Equipment Specialist (CRES) by the Advancement of Medical Instrumentation: International Certification Commission/United States Certification Commission (AAMI: ICC/USCC), and has an Associate of Applied Science in Electronics Engineering Technologies. Graham is pursuing a Bachelor of Science in Biomedical Electronics. He also served in the U.S. Army and was deployed for 16 months to Baghdad, Iraq, with the 1st Armored Division.
CDR Kimberly Lewandowski-Walker CDR Kimberly Lewandowski-Walker is a National Expert in Medical Devices for the Food and Drug Administration, Division of Field Investigations. She holds a Doctor of Optometry Degree from Indiana University, a Master of Science in Human Services from Capella University, and a Bachelor of Science in Biology from Indiana University. She served as a Clinical Optometrist for Indian Health Service for 5 years prior to transferring to FDA as a Consumer Safety Officer in the Minneapolis District, Milwaukee Resident Post. In her current capacity as National Expert, she serves as Instructor in the FDA Basic Medical Device course and in the FDA Process Validation for Medical Devices course.
Reynaldo R. Rodriguez Reynaldo R. Rodriguez Jr is the Dallas District Director. He has been in his current position since February, 2008. Prior to this position, he served as the Compliance Branch Director in Dallas, a Compliance Officer, Supervisory Investigator, and Investigator. He began his career with FDA in 1983, and has a wide breadth of inspectional and compliance experience across all FDA program areas. Ricky received his Bachelor of Arts degree in Biology/Chemistry from St. Mary’s University, San Antonio, Texas, in 1983, and received his Master of Arts degree in Public Administration from Webster University, St. Louis, Missouri, in 1986.
Jeff R. Wooley Jeff R. Wooley is an Investigator for the FDA Dallas District Office since 2007. He currently performs medical device and drug inspections throughout the Dallas District Office area of coverage (Texas, Oklahoma, and Arkansas) and has conducted international inspections. He earned his Bachelor of Science Degree in Biology from Sam Houston State University in 2007.