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The term human factors is very important to those who develop and market medical devices. Creating simpler, safer, more user-friendly products is a key objective for medical device manufacturers wishing to be competitive in today's medical device markets. Medical device manufacturers are required by FDA and other international regulatory bodies to demonstrate how human factors considerations were met during their product's development. A panel of experts will provide tips for integration of human factors into the product development process, clarify regulatory obligations and review the rationale behind these requirements, discuss how to strengthen regulatory submissions by highlighting human factors activities and findings and provide guidance on the difficult issue of how to determine the right level of investment in human factors given a device's inherent risk.

Moderator:
Shelley Trimm
Alquest

Panel Speakers:
Mark Brecht
Human Factors Engineer, BRECON Design

Rachel Hinman
Mobile Design Strategist, Adaptive Path Inc.

Lisa Rogan
Sr. Director, Marketing, Pelikan Technologies Inc.

Greg Kapust
President and CEO, Breathe Technologies, Inc.

• When: May 12, 8:00am - 10:00am
• Where: Cooley Godward Kronish LLP, Palo Alto, CA Directions.
• Attire: Business Attire Suggested

THIS EVENT IS SOLD OUT

• Pre-registered attendees will receive an immediate receipt/confirmation after submission.
  Please print this receipt/confirmation and bring it with you to receive your conference credentials.
  Photo ID (driver's license or passport) will be required at check-in.
• All sales are final - BayBio offers no refunds.

Please mail your event-related questions to: events@baybio.org or you can contact us via phone: 650-871-7101.
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