Device research can feel intimidating, particularly when studies involve less familiar categories such as in vitro diagnostics (IVDs), humanitarian use devices (HUDs), and software as a medical device (SaMD). Uncertainty about regulatory pathways and ethical considerations often complicates IRB review and decision-making.
This 90-minute online workshop is designed to demystify common—and commonly misunderstood—types of device research. Through clear explanations, practical frameworks, and applied examples, attendees will gain confidence in navigating regulatory requirements and ethical considerations across a range of device categories. The session emphasizes real-world IRB review strategies that can be applied immediately, even when facing complex or novel device protocols.