Paul & Elisabeth Merage Foundation | Andre & Katherine Merage Foundation


Edward John Allera

Edward John Allera

Co-Managing Shareholder

Buchanan Ingersoll & Rooney PC, Washington, DC Office

Class Overview

  • Overview of medical device regulatory processes in the United States
  • Use and design of computerized systems in clinical trials.
  • Important issues in the premarket design and analysis of device trials.
  • Synopsis of quality systems and import requirements for medical devices.
  • Development process of a post-marketing plan including the post approval study outline.
  • Review clinical case studies involving medical devices.
  • Best practices and tips to prepare for good clinical practice inspections.