Understanding and applying human factors is essential to ensuring product usability and user satisfaction. More importantly, consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation each week to cover core concepts and demonstrate how human factors fit into the larger context of medical device software and hardware development. Lessons address the integration of human factors and usability into the product development lifecycle, regulatory considerations, including applicable FDA guidance and standards (ANSI/IEC), and human factors methods.
The course is beneficial for professionals who already have a basic understanding of risk management and quality systems, as well as a broad range of technical professionals, including those with no prior medical device experience.
At the conclusion of the course, you should be able to
- Define the role of human factors in the medical device design process
- Understand appropriate human factors methodologies for the development of medical devices
- Identify human factors standards relevant to medical device development.
- Review human factors documentation against the standards and process.
- Discuss human factors engineering requirements.
- Identify usability issues related to product design.
- Applicable Standards/Guidance Documents
- Task/Workflow Analysis
- Formative & Summative Evaluations
- 62366 Checklist
Working knowledge of:
- Communication and collaboration tools such as Google Workspace, Microsoft Office, or LibreOffice
- Learning Management Systems (LMS) such as Canvas including navigation links, modules, etc.
Additional InformationPlease review section notes to view the full schedule.
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Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
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