Medical Device Clinical Investigations: An Introduction to Sponsor Responsibilities and Compliance Issues Identify the responsibilities of clinical trials sponsors and investigators. Recognize examples of Adverse Event Reporting (AER).Become familiar with the purposes of Bioresearch Monitoring (BIMO). Rebecca Jones McKnight , Partner, DLA Piper LLP (US) REBECCA (BECCA) JONES McKNIGHT is an [...]

Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments Define registration and listing and their applications to the medical device industry. Assess who does and who does not have to register and list and how the process works. Abeba Habtemariam , Counsel, Arnold & Porter LLP ABEBA HABTEMARIAM [...]