Document user testing results proving interface safety and regulatory compliance achievement.
Task | Participants | Success Rate | Average Time | Use Errors | Critical Task |
---|---|---|---|---|---|
T-001: App setup | 15 | 100% | 3.2 min | 0 | No |
T-002: Electrode placement | 15 | 93% (14/15) | 4.8 min | 1 | Yes |
T-003: ECG recording | 15 | 100% | 2.1 min | 0 | Yes |
T-004: Emergency response | 15 | 100% | 1.4 min | 0 | Yes |
T-005: Symptom reporting | 15 | 87% (13/15) | 5.3 min | 2 | No |
How should use errors and difficulties be analyzed in the usability report?
What should be done if critical tasks fail during usability testing?
How should formative evaluation activities be documented in the report?
How should usability testing results be integrated with risk management?
What conclusions should be drawn from usability evaluation results?
How should post-market usability surveillance be planned based on testing results?