Human Factors and Usability Engineering is no longer a best practice — it is a regulatory imperative. The FDA will deny approval for any medical device where it cannot be demonstrated that the risk of use error has been systematically designed out. With the QMSR now in full effect as of February 2, 2026, the bar has been raised further: Risk-based thinking must permeate the entire Quality Management System, including Human Factors.

If your Human Factors program was built under the old QSR, it may already be non-compliant. If your usability studies don’t reflect IEC 62366-1 + AMD1:2020 — including updated critical task definitions aligned with FDA terminology — your summative evaluations are structurally at risk. And if your team hasn’t mapped the implications of FDA’s 2025 AI-device draft guidance to your HF validation process, you’re behind your competition.

This webinar delivers a rigorous, end-to-end walkthrough of how to build, execute, and validate a Human Factors program that satisfies current FDA expectations and aligns with the latest standards. Attendees receive practical specification templates, user interface evaluation templates, and usability validation control forms that can be immediately applied to active programs. The session addresses the QMSR transition, the FDA’s draft HF submission content guidance, and AI-device HF implications—giving attendees the tools to audit their own programs before FDA does it for them.

After this webinar attendees will be able to answer:

• What is the regulatory distinction between ‘user error’ and ‘use error’—and why does it make every use error a device nonconformity under FDA’s framework?
• How does the new QMSR (21 CFR Part 820, effective Feb 2, 2026) change Human Factors obligations under ISO 13485:2016 design controls—and are your current SOPs already non-compliant?
• What HF documentation must now be included in marketing submissions per FDA’s December 2022 draft guidance — and what happens to submissions that miss it?
• How do you build a step-by-step Human Factors Engineering program that simultaneously satisfies ISO 62366-1 and FDA expectations—without duplicating effort?
• What is a use-related hazard analysis and how is it structurally different from general risk analysis under ISO 14971:2019—a distinction many QA professionals get wrong?
• How should User Profiles, Use Scenarios, and critical tasks be developed and documented to survive FDA reviewer scrutiny?
• What does a defensible summative (validation) usability study look like—and what are the most common structural flaws that lead to Additional Information requests?
• How does FDA’s January 2025 AI-device draft guidance alter Human Factors validation, use-related risk analysis, and UI design requirements for AI-enabled devices?

This webinar benefits the following agencies:

• Medical Device Manufacturers (Class II & III device makers with FDA submissions)
• Contract Research Organizations (CROs) supporting HF studies and design validation
• Notified Bodies and ISO 13485 Certification Auditors
• FDA CDRH submissions reviewers and compliance professionals
• EU MDR compliance teams managing IEC 62366-1 alignment
• Organizations transitioning from QSR to QMSR and updating design control SOPs

Who should attend?

• Design / R&D Engineers
• Engineering Management
• Quality Assurance
• Regulatory Affairs