Integrating Human Factors Engineering into the Product Development Lifecycle


Instructor: Elizabeth Bononno
Product ID: 706624
Training Level: Intermediate

  • Duration: 90 Min
This webinar will discuss how to integrate Human Factors Engineering into the product development lifecycle of an organization as per the requirements of the FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices (2_2016) and IEC62366-1 Application of usability engineering to medical devices (2_2015). Understanding the deliverables described in these standards can lead to the successful creation of standard operating procedures, the ability to accurately determine the scope of work and necessary budget, appropriate project deliverables and organizational buy-in.
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Why Should You Attend:

This webinar provides individuals with an opportunity to understand how to navigate what the Human Factors standards require for each phase of the product development lifecycle and the expected deliverables based on the type of product being developed. Usability engineering is a customer focused team effort that requires buy-in from not only the R&D Team, but the entire organization. This webinar will provide you with the tools to understand the deliverables required by Human Factors standards and how integrate them into your organization’s product development lifecycle.

Without a clear understanding of the deliverables required by FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices and IEC62366-1 Application of usability engineering to medical devices, companies may face delays bringing their product to market or worse yet receive warning letters for products currently on the market. Over the years there has been an increased focus on medical device manufacturers ability to provide safe, effective, efficient products that are free from potential use errors that could compromise patient outcomes. Understanding the standards, effectively implementing them as an organization and establishing buy-in regarding their importance to your organization can save years of development time and unnecessary expenses.

As per the current standards for Human Factors Engineering, companies creating new medical devices, refreshing existing medical devices on the market or who are manufacturing medical devices prior to the creation of the standards are required to provide objective evidence that they have adhered to them. Depending on the size of an organization, the Human Factors team may provide these deliverables independently or outsource them to a third party. Ultimately a consistent approach to the interpretation of the standards is the responsibility of the parent company manufacturing the medical device and therefore requires an understanding of them, the ability to provide the appropriate deliverables depending on the scope of work and provide accurate documentation regarding the outcome.

Areas Covered in the Webinar:

  • What is Human Factors / Usability Engineering
  • Why is it important
  • International and U.S. Standards
  • Usability Engineering deliverables
  • Who owns the deliverables
  • When are they needed
  • How do they fit into the product development lifecycle
  • Tailoring the effort depending on the scope of the project
  • Organizational benefits

Who Will Benefit:

  • Human Factors Engineer
  • Usability Engineer
  • Project Manager
  • Product Manager
  • Marketing
  • Requirements Engineer
  • Software Engineer
  • Mechanical Engineer
  • Systems Engineer
  • Quality Engineer
  • Risk Management
  • R&D Leadership
  • Customer Service
  • Field Service
Instructor Profile:
Elizabeth Bononno

Elizabeth Bononno
Owner and Founder, EB-UX Consulting, LLC

Elizabeth Bononno is an accomplished business owner, AAMI Human Factors Board Member and Certified Usability Analyst who brings a diverse skill set to strengthen and improve the client and user's experience. Her experience spans over 25 years of practical Marketing, Product Management, User Experience and Design Validation knowledge with medical devices and business to consumer website content research, development and analysis. Her mission is to ensure the customer and device interface quality come first through the education of teams, effective interpretation of industry standards and creation of functional practices that establish a customer focused culture and a trusted, empowered organization.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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