ME 6788: Legal Issues in Biomedical Engineering

Credit Hours: 3-0-3
Prerequisites: Graduate standing.
Catalog Description: Study and analysis of U. S. government laws applicable to the development and clinical use of biomedical engineering technology. Crosslisted with BMED, CHE, ECE, and MGT 6788. Taught jointly with School of Management with cross-listing.
Instructors: David Ku (ME), Terry Blum (MGMT)
Topics:
  1. Governing laws on medical devices and pharmaceuticals.
  2. Intellectual property rights, protection, infringements.
  3. Patent application, claims.
  4. Licensing agreements.
  5. FDA regulations and approval processes.
  6. Legal aspects of the global marketplace.
Instruction (%):

Lecture

100