Human Factors for Medical Devices

AAMI's recurring human factors course returns as a three-day session, 15–17 December 2026, with presenters from FDA's CDRH and CDER on device usability expectations, human factors evaluation and testing, and how the agency reviews human factors data premarket.

Dates and format

• Dates: 15–17 December 2026
• Schedule: three days, 9:00 a.m.–6:00 p.m. ET each day
• Format: listed here as virtual pending confirmation — AAMI's human factors course also runs an in-person Arlington, VA track at other points in the year
• Organizer: AAMI (Association for the Advancement of Medical Instrumentation)

What it covers

The course walks through the human factors processes that shape medical device design and how they affect device safety: user models, task analysis, contextual inquiry, heuristic evaluations and the relevant human factors standards, combined with hands-on exercises and case studies. AAMI's listing describes FDA presenters from CDRH and CDER discussing the agency's usability expectations, how human factors evaluation and testing work in practice, and how that data moves through premarket review.

Who should attend

Human factors, usability and design-control leads building or updating a device's HF program, and regulatory affairs professionals who need to understand how FDA reviewers read human factors data in a submission. AAMI runs this course several times a year, with March, June and September 2026 offerings already behind this one.

Assembling a submission around the same timeline? AAMI's Navigating 510(k) & De Novo Requirements course runs the month before, and the full events directory lists everything we have verified.