Incorporating Human Factors into the Risk Management Process

Elizabeth Bononno
Mar 16, 2021 - 01:00 PM EDT
Starting at

$249


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This webinar will discuss how to integrate Human Factors Engineering into the Risk Management process 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) and ISO 14971 Medical devices - Application of risk management to medical devices (12_2019). Both Human Factors Engineering and Risk Management standards are complementary in their goals to reduce the safety risks associated with medical devices to levels as low as reasonably possible. This webinar presents organizations with opportunities and insights on how to align and streamline their approach.

Why Should You Attend:

Following Risk Management standards is essential for medical device manufacturers, but what about the risks associated with the tasks of the users of your medical device? Have you factored humans using your medical device into your risk management analysis? The standards for medical device risk management and human factors risk management are complementary. Understanding how to consider both will allow you to not only consider risks that may occur during the design, development, and commercialization of the medical device, but also the risks that are inherent due to human nature and the tasks your users perform when using medical devices. U.S. and International standards are coming together to embrace not only the risks of the device itself but risks associated with users of the device and point to a growing awareness that both are important to patient outcomes and safety.

Both Human Factors Engineering and Risk Management standards have similar goals with regard to the reduction of risk related to safety of medical devices. Rather than seeking to address the standards individually, a comprehensive understanding and approach to both disciplines can be employed to streamline risk based analysis and data collection throughout a product’s design, development, and commercialization. Understanding the goals of the standards as they relate to users safe and effective use of the product provides the opportunity to leverage the synergies between both disciplines and reduce risks throughout the product development lifecycle.

This webinar will provide individuals with an opportunity to understand the goals of both Human Factors and Risk Management processes pertaining to the reduction of risks related to end user and medical device safety. In addition, the complementary parallels and opportunities for data collection and analysis throughout the product development lifecycle will be explored.

Areas Covered in the Webinar:

  • What is Medical Device Risk
  • When should it be Considered
  • Medical Device Risk Considerations
  • Benefits of Risk Management
  • Risk Management – Outside of Medical Devices
  • Human Factors and Risk Management
  • Who are your users and what are their tasks
  • What is a use error
  • Collection & Analysis of Risk Based Safety Data
  • Maintaining Risk Management throughout the product development lifecycle
  • Synergies between Risk Management standards

Who Will Benefit:

  • Human Factors Engineer
  • Usability Engineer
  • Project Manager
  • Product Manager
  • Requirements Engineer
  • Software Engineer
  • Mechanical Engineer
  • Systems Engineer
  • Quality Engineer
  • Risk Management
  • R&D Leadership
  • Customer Service
  • Field Service
  • From Medical, Healthcare, Diagnostics sectors
Webinar Events
Attend Live Webinar
Mar 16, 2021 - 01:00 PM EDT

Duration: 90 Minutes

Single Attendee


Group-Max. 10 Attendees/Location (For Multiple Locations Contact Customer Care) Super Deal - Get CD/USB Drive Free!


LIVE + RECORDED VERSION


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: 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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