# Usability Evaluation Report

Author: Dr. Oliver Eidel
Published: 2022-06-09
Updated: 2024-05-18
Source: https://openregulatory.com/document_templates/usability-evaluation-report

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Usability Evaluation Report
The Usability Evaluation report describes the results of all (formative and summative) Usability Evaluations.
Mapping of Standard Requirements to Document Sections
IEC 62366-1:2015 Section	Title	Document Section	
4.1.3	Information for Safety as it relates to Usability	4.5	
4.2	Usability Engineering File	(all)	
1. Relevant Processes
Usability Engineering and Evaluation activities are defined in the SOP Integrated Software Development.
2. Related Documents
List of Hazard-Related Use Scenarios
Usability Evaluation Protocol
Usability Evaluation Plan
3. Summary of Formative Evaluations
3.1 Formative Evaluation 1
4. Summary of Summative Evaluation
4.1 Methods
Copy-paste this section from the Usability Evaluation Plan (5.2 Planning (Setting)).
4.2 Overview over Tests
Copy-paste this table from the Usability Evaluation Protocol.
ID	Description	App State / Environment	Instructions	Acceptance Criteria	Observations	Hazards encountered	
							
4.3 Pass / Fail Counts of Tests
Count the pass/fail results from the Usability Evaluation Protocol
Test ID	Description	Total Count	Pass Count	Fail Count	
					
4.4 Use Errors and Hazards
Test ID	Description	Use Error	Potential Hazard	
				
4.5 Information for Safety
Describe whether information for safety could correctly be perceived and understood by the users and
whether it supported the correct use of the medical device.
4.6 Other Findings
5. Qualitative Participant Feedback
6. Conclusion
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