# Usability engineering / human factors plan (outline)

**Device / SaMD version:**  
**Date:**  
**Lead:**

## Intended users, use environment, and training

- User profiles:
- Use environments (home, clinic, ambulance, etc.):
- Training and labeling assumptions:

## Critical tasks

List tasks where use error could lead to harm.

| Critical task | Related hazard (ISO 14971 ref) | Severity |
|---------------|-------------------------------|----------|
| | | |

## Formative evaluation

- Methods (interviews, simulated use, cognitive walkthrough):
- Iteration log (finding → design change):

## Summative validation

- Protocol ID; sample size rationale:
- Acceptance criteria (task success, assist rate, time):
- Residual use-related risks and labeling mitigations:

## Post-market usability feedback

- Complaints and use-error signal review cadence: