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San Francisco Bay Area Chapter Webcast: Applying Human Factors Engineering in Medical Device Development – Regulatory Expectations and Trends

RAC Credits
Friday, 13 November 2020 (11:00 AM) - Friday, 13 November 2020 (1:00 PM) Pacific Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


This webcast will 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. 

The 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.

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

The webcast will conclude with a Q&A session. 

This event is brought to you by the RAPS San Francisco Bay Area chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

Learning Level: 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

This webcast is available to RAPS members for free
. RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speakers:
Jason Amaral, senior director, R&D, Abbott
Jennifer Mascioli-Tudor, vice president, quality Assurance, regulatory affairs, program management &OpEX, Outset Medical
Michael Wiklund, MS, CHFP, general manager, Emergo by UL’s Human Factors Research & Design Team, professor of the practice, Tufts University