Casemaker Libra

Medical Device Law- Compliance Issues, Best Practices and Trends

Publication Year: 2015   Publication Type: Book

Joel M. Androphy, Yogesh Bahl, Ali Behbahani, M.D., Philip S. Brewster, Michael A. Carvin, Michael E. Clark, Lisa W. Clark, David L. Douglass, David K. Elder, Stephanie J. Fertig, Matthew R. Fisher, Andrew Gantt, Sonali Gunawardhana, Colleen Heisey, Sheila Hemeon-Heyer, Gail Hannah Javitt, Joy J. Liu, Mary K. Logan, John Manthei, Clinton Royce Mikel, Timothy M. Moore, Gregory F. Noonan, Maura M. Norden, Justin P. O'Brien, Mauricio F. Paez, Hemant Pathak, Philip Phillips, Robert "Bob" T. Rhoad, John L. Robertson, Randy V. Sabett, Jennifer A. Short, Nancy Singer, Julie Taitsman, John Reed Thomas

Table of Contents:

 Faculty and Author Biographies
 Section A- Hot Topics in Medical Device Law
 Section B- Advanced Issues in Medical Device Law
 Section C- Industry Perspective On Past Years' FDA Compliance Guidance
 Section D- Financing Medical Devices Through Conventional and Unconventional Means
 Section E- Compliance Issues For Emerging and Novel Technologies
 Section F- Evolving HIPAA and Privacy Issues For the Medical Device Industry
Section G- Practical Cyber Security For the Device Industry
 Section H- Regulatory Risk Management and Mitigation (Ethics CLE)