Single logo
LoginSign Up

Medical Device Usability Engineering Audit Checklist

A comprehensive checklist for auditing usability engineering processes in medical device development, ensuring compliance with ISO 13485 and IEC 62366 standards and improving overall device safety and user experience.

Medical Device Usability Engineering Audit Checklist

by: audit-now
4.6

Get Template

About This Checklist

The Medical Device Usability Engineering Audit Checklist is a vital tool for healthcare organizations to ensure compliance with ISO 13485 and IEC 62366 standards in human factors and usability engineering processes. This comprehensive checklist addresses critical aspects of user-centered design, usability testing, and user interface evaluation for medical devices. By implementing robust usability engineering practices, manufacturers can significantly reduce use errors, enhance user experience, and improve overall device safety. This checklist aids in systematically evaluating user needs analysis, usability specifications, formative and summative usability testing, and user interface design, ultimately contributing to the development of more intuitive and safer medical devices in the healthcare industry.

Learn more

Industry

Healthcare

Standard

Medical Device Usability Standards

Workspaces

Medical Device Manufacturing Facilities

Occupations

Human Factors Specialist
User Experience Designer
Clinical Applications Specialist
Quality Assurance Manager
Regulatory Affairs Specialist
1
Is the user-centered design process being adhered to throughout the development of the medical device?
2
What is the overall score from the usability testing conducted on the medical device?
Min: 1
Target: 4
Max: 5
3
Please provide a summary of the feedback received from users during the usability testing.
4
Has a human factors evaluation been conducted as part of the usability engineering process?
5
What notes or comments do you have regarding regulatory compliance related to usability?
6
Does the user interface design comply with the guidelines set forth in ISO 13485 and IEC 62366?
7
What was the error rate observed during user interface testing?
Min: 0
Target: 5
Max: 100
8
What suggestions do users have for improving the user interface design?
9
How satisfied are users with the user interface of the medical device?
10
What specific issues were identified during the user interface evaluation?
11
Has a comprehensive human factors analysis been completed for the medical device?
12
What is the severity rating of identified usability risks on a scale from 1 to 10?
Min: 1
Target: 5
Max: 10
13
What strategies have been implemented to mitigate identified usability risks?
14
Has user training been provided to address usability concerns?
15
What feedback has been received from regulatory bodies regarding usability?
16
Have the predefined usability goals for the medical device been achieved?
17
What is the task completion rate observed during usability testing?
Min: 0
Target: 90
Max: 100
18
What observations were made during the usability testing sessions?
19
What was the error identification rate during the usability evaluations?
20
What recommendations do you have for improving the usability of the device?
21
Have accessibility features been implemented in the medical device design?
22
What is the score from the accessibility compliance evaluation on a scale of 1 to 10?
Min: 1
Target: 7
Max: 10
23
What feedback have users provided regarding the accessibility of the device?
24
Was usability testing conducted with a diverse group of users, including those with disabilities?
25
What barriers to accessibility have been identified in the device?

FAQs

The checklist covers areas such as user research, use environment analysis, task analysis, usability goals and objectives, user interface design principles, formative and summative usability testing, risk analysis related to use errors, and usability validation.

It includes specific items to verify that user needs are properly identified and addressed throughout the design process, usability testing is conducted rigorously, and potential use-related hazards are mitigated effectively.

The audit should involve human factors specialists, user experience designers, clinical experts, quality assurance personnel, and regulatory affairs professionals to ensure a comprehensive evaluation of usability aspects.

Usability engineering audits should be performed at key milestones during product development, before major design iterations, and as part of the final validation process before product release.

Inadequate usability engineering can lead to user errors, patient harm, device misuse, poor user adoption, increased training costs, regulatory non-compliance, and potential product recalls or liability issues.

Benefits of Medical Device Usability Engineering Audit Checklist

Ensures compliance with ISO 13485 and IEC 62366 usability engineering requirements

Reduces the risk of use errors and improves patient safety

Enhances user satisfaction and device adoption rates

Improves device efficiency and effectiveness in clinical settings

Facilitates regulatory approvals by demonstrating comprehensive usability considerations