Applying Human Factors Engineering in Medical Device Development – Regulatory Expectations and Trends

Learning objectives for this webcast: 

  • Understand how integrating human factors engineering into an overall development process may accelerate the process; ensure a safe, effective and satisfying product; and facilitate regulatory acceptance
  • Articulate the value and best approach to key human factors activities 
  • How to get the maximum benefit from an investment in human factors engineering, starting early in the device development process 
  • Cite examples of how human factors engineering has been applied with success to produce an exemplary medical device

Understand and be better prepared to mitigate compliance risks by applying human factors engineering to the necessary and advantageous extent

Nov 13, 2020

Friday, November 13, 2020 | 11 am Central

Michael Wiklund, General Manager of Emergo by UL’s Human Factors Research & Design team, joins a team of experts to review a general introduction to human factors engineering (aka usability engineering) as it pertains to Class II medical devices that are subject to design controls. There will be a clarification on the importance of meeting the US Food and Drug Administration’s (FDA) human factors expectations in advance of making a 510(k) submission, and how it may also improve a medical device’s chance of commercial success. 

This webcast will cover trends in how the medical industry applies human factors engineering to positively affect and reduce the prevalence and severity of harms due to medical device use errors. The content will evaluate the importance of human factors across the product development life cycle, addressing why R & D leaders should embrace human factors engineering to maximize value in a program and how it fits in with best practices design thinking and agility.

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