Use errors are a leading cause of medical device recalls and patient harm. FDA's 2016 guidance requires documented evidence that devices minimize use errors.
FDA Guidance Reference: "Applying Human Factors and Usability Engineering to Medical Devices" (FDA-2011-D-0469)
A systematic approach aligned with FDA guidance to identify, analyze, and mitigate use-related risks
Define intended users, their characteristics, training levels, and use environments
Identify potential use errors and their severity through systematic hazard analysis
Determine which tasks could cause serious harm if performed incorrectly
Iterative testing with representative users to refine design and reduce use errors
Apply human factors principles to eliminate or mitigate identified risks
Summative testing demonstrating device can be used safely by intended users
We help you determine the appropriate level of human factors documentation based on your device's risk profile
Device changes do not affect use-related hazards. Limited HF information required.
Changes affect hazards but do not add or impact critical tasks.
Device has critical tasks or modifications that impact critical tasks.
We prepare all eight sections recommended by FDA for human factors submissions
Conclusion and high-level summary of human factors testing
Description of intended users, uses, and use environments
Device user interface description and design rationale
Summary of known use problems with similar devices
Analysis and summary of preliminary evaluations
Use-related hazards and risk analysis results
Critical task identification and rationale
Human factors validation testing details and results
Human factors expertise across the full spectrum of medical devices and combination products
Medical Device Software (SaMD)
Drug Delivery Systems
Diagnostic Devices
Combination Products
Patient Monitoring Devices
Surgical Instruments