Goal: The goal of this workshop is to equip clinical research professionals with the knowledge and practical skills needed to effectively conduct and manage medical device clinical studies. Participants will gain a stronger understanding of FDA regulatory requirements, operational best practices, compliance responsibilities, and financial considerations to ensure patient safety, regulatory compliance, and the successful execution of medical device research.

Member Rate: $295.00

Non-Member Rate: $370.00

Objective: By the end of this workshop, participants will be able to identify key FDA regulatory requirements and pathways for medical device research, understand sponsor and investigator responsibilities, and apply Good Clinical Practice (GCP) principles. Attendees will also be able to demonstrate an understanding of device accountability, documentation, Medicare coverage, research billing, and risk management to support regulatory compliance, patient safety, and the effective conduct of medical device clinical studies. Please contact us with any questions or concerns at [email protected].

Learning Objectives: Upon completion of the workshop, the attendee should be able to:

2. Recognize Roles and Responsibilities

3. Apply Good Clinical Practice (GCP) Principles

4. Manage Device Operations and Documentation

5. Understand Medicare Coverage and Research Billing

6. Identify and Mitigate Compliance Risks

7. Apply Knowledge to Real-World Scenarios