Human Factors Engineering in Medical Device Development


This one-day course is presented by an experienced human factors engineer who specializes in medical device development and has played an active role in the development of current human factors engineering standards. The course will give attendees a firm understanding of the human factors engineering process as it applies to medical device development, fully accounting for regulators' expectations and today's standard practices.


Workshop Topics

  • Integrating human factors engineering with other product development activities
  • Scaling the human factors engineering process to suit the product in development
  • Establishing quantitative usability goals and acceptance criteria
  • Preparing user profiles, use environment descriptions, and use scenarios
  • Developing user requirements
  • Identifying and mitigating use-related risks
  • Designing user interfaces in accordance with human factors engineering principles and standards
  • Planning, conducting, and reporting the results of usability tests
  • Writing human factors engineering reports


  • Understand human factors engineering expectations set by IEC 60601-1-6 and IEC 62366
  • Understand various regulatory bodies' expectations for human factors engineering
  • Understand the resources required to implement a comprehensive human factors program
  • Plan human factors engineering programs that are properly scaled to the medical device in development
  • Ensure that a design history file contains the necessary human factors engineering end-products

Target Audience

  • Regulatory compliance managers and engineers
  • Quality assurance specialists
  • Development project managers
  • Human factors specialists (new to the medical device industry)
  • Hardware user interface designers
  • Software user interface designers
  • Software developers
  • Documentation designers and writers
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Time Requirement


Instructor-Led 1 day $675.00

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