2018 Speakers

We’re very excited about our 2018 speaker lineup. Interested in joining as a speaker next year?
Come to Dr. David Mullis after the conference is finished.

 

 

Blake Bevill

Blake Bevill, M.S.

Program Division Director, OMDRHO, Division 2 Central  

Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections.  He accepted a Supervisory Investigator position in 2001.  Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives.  He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014.  He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations.  As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO.  He graduated from Harding University with a Bachelor’s degree in Biology, Arkansas State University with a Master’s of Science degree in Biology, and completed a Senior Executive Development program at George Washington University.

 

Seth D. Carmody

 

 

 

Seth D. Carmody, Ph.D.

Cybersecurity Program Manager

Dr. Carmody is the Cybersecurity Program Manager for the Center for Devices and Radiological Health, serving as co-chair of CDRH’s Cybersecurity Working Group.  The Cybersecurity Working Group is an interdisciplinary team responsible for the FDA’s final pre- and post- market cybersecurity guidance’s as well as incident response.  Seth joined CDRH in 2011 as a medical device reviewer.

 

Lena Cordie

 

 

 

Lena Cordie

Qualitas Professional Services

Lena Cordie has over 20 years of quality and project management experience including: 1o years in project management at Target Financial Services, 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement sustainable quality management systems and globally compliant unique device identification (UDI) programs, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of: AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee, AHRMM LUC (Association for Healthcare Resource & Materials Management Learning UDI Community), ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups, RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter, and is a member of the RAPS European Council.

 

Mark DuVal

 

 

 

Mark DuVal, J.D.

President of DuVal & Associates, P.A

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training, and interfacing with the FDA in relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.  He works extensively with FDA on 510(k)s, de novos, PMAs and combination products, IDE negotiations, Pre-Submissions, inspections, warning letters, appeals, etc.

Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems, working both domestically and internationally.  For almost a year, he was on assignment for 3M Health Care Systems, Ltd. in Europe, based out of the United Kingdom. He then worked at Medtronic in as FDA regulatory counsel and also as corporate compliance counsel for Anti-kickback, False Claims Act, HIPAA & HITECH, Physician Payments Sunshine Act and other advice related to the FDA-regulated industry.

Mark co-founded the Minnesota Medical Device Alliance (MMDA) and has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Bio sciences Council (appointed by Governor Tim Pawlenty), The Food and Drug Law Institute (FDLI), and the Food, Drug and Medical Device Section of the Minnesota State Bar Association, on which he served as chairman.  He is also on the Board of Advisors of the Masters in Regulatory Affairs and Sciences program at St. Cloud State University, a Fellow for the Regulatory Affairs Professional Society (FRAPS), and a leader in medical device scholarship and public policy advocacy.

Mark is a frequent speaker on FDA, both domestically and internationally, and writer on issues relating to per-submission meetings, product clearances and approvals, combination products, product advertising and promotion, and Anti-kickback and False Claims Act (reimbursement) and other regulatory matters.

 

Matthias Fink

 

 

 

Matthias Fink, M.D.

Board Certified Orthopedic and Trauma Surgeon
Clinical Reviewer
Global Team Leader Ortho and Trauma
Clinical Centre of Excellence
TÜV SÜD Product Service GmbH
Munich, Germany

Board certified orthopedic surgeon and trauma surgeon with more than 17 years of professional experience in Orthopedic and Trauma Surgery and extensive training in Cardiovascular and Thoracic Surgery. Expert knowledge in the field of orthopedic implants and cardiac devices. Investigator and Co-investigator in clinical studies for medical device and pharmaceutical companies.

Since 2016 internal Clinical Reviewer for the Clinical Centre of Excellence and Medical Expert for the Clinical Audit Team for TÜV SÜD in Munich, Germany. Experience with Clinical Audits inside and outside the European Union. Presenter and discussant at national and international conferences. Since 2018 Global Team Leader for the Ortho and Trauma Team within the Clinical Centre of Excellence.

 

Keith Morel

 

 

 

Keith Morel, Ph.D.

VP of Regulatory Compliance at Qserve Group

Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, one of the largest European-based medical device consulting companies. He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer). Keith was also a Senior Project Manager for DEKRA Certification for 9 years.  During his time at DEKRA he was a quality system and regulatory lead auditor, as well as a design dossier reviewer. He performed more than 100 audits and 200 Design Dossier/Technical File reviews. Before DEKRA, Keith worked in R&D in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products.  He holds both a First-Class degree and a Ph.D. in Physics from Imperial College of Science, Technology and Medicine, in London.

 

David W. Mullis, Jr

David W. Mullis, Jr., M.S., Ph.D., RAC, FRAPS

Director of the International Biomedical Regulatory Sciences Graduate Education Programs

Dr. Mullis is the Director of the International Biomedical Regulatory Sciences Graduate Education Programs within the College of Pharmacy at the University of Georgia. He also holds the rank of Associate Professor in the College of Pharmacy, Department of Pharmaceutical and Biomedical Sciences. Dr. Mullis serves as President of Mullis & Associates, Inc., a consulting firm that provides regulatory affairs and clinical studies support services for pharma, biotech, medical device and animal health companies. Dr. Mullis has over 40 years of successful senior management experience working in the FDA regulated health care industry including 19 years as a consultant with companies. He has extensive experience filing IDEs, INDs, 510(k)s, PMAs, and other marketing applications with FDA and international regulatory agencies. He assists clients with resolving submission problems, cGMP, GCP and other regulatory compliance issues. Dr. Mullis holds a BS degree from Appalachian State University, a Master of Science from The University of Tennessee, and a Ph.D. from The University of Tennessee. He is a Fellow in the Regulatory Affairs Professional Society that recognizes senior regulatory affairs professionals for their continued significant contributions and leadership in the advancement of the profession and is a member of the AGRE Board of Directors. Dr. Mullis is a city council member and Vice-mayor for the city of Good Hope, GA and serves on the board of directors for multiple small business entities.

 

Ibim B. Tariah

Ibim B. Tariah, Ph.D.

Technical Director for BSI Healthcare

Dr. Ibim Tariah is the Technical Director for BSI Healthcare. He earned his PhD in Materials Science with emphasis on polymer science and technology from the University of Manchester, U.K.

Dr. Tariah has over 24 years experience in the medical device industry in which he led global organizations in successful product development, project management and provided technical expertise in support of commercial efforts. In the years, since coming to BSI, Dr. Tariah has been providing expertise in vascular, orthopaedic & dental and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Directive (MDD) and development & delivery of specialized MDD training courses. His vast experience includes Regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics along with Quality Assessment of Medical Devices. He also acts as a liaison with Regulatory Authorities including MHRA (UK), European Medicines Agency (EMA), Medical Products Agency (Sweden).