Human Factors Testing Webinar

Bryant Foster, from Research Collective, recorded a free webinar on the topic of human factors testing for 510k submissions on September 24, 2019.

Research Collective Logo 1024x198 Human Factors Testing Webinar

The human factors testing webinar was presented by Bryant Foster on September 24, 2019. It’s free to register as long as you ask Bryant a question.

What you will learn in our human factors testing training webinar

This webinar explains how usability engineering fits within the overall context of a quality system and control of design controls. The origins of human factors/usability engineering are presented as a story with an instructive example from the aviation industry. The differences between formative usability testing and summative usability testing is explained. Finally, the rationale for the minimum number of users in validation of usability is explained.

This webinar will cover parts of the following standard and guidance:

  • IEC/ISO 62366-1(2015)
  • Applying Human Factors and Usability Engineering to Medical Devices – FDA

The webinar was recorded using Zoom, and registrants will receive a link to download a copy of the slide deck and the webinar recording. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.

Which standards does the FDA Recognize for the human factors process?

The FDA officially recognizes device-specific and general consensus standards published by national and international standards bodies. Standards recognized by FDA related to the human factors process and application of Human Factors Engineering/Usability Engineering (HFE/UE) to medical devices can be found in a table published by the FDA.

Additional Training Resources for Usability Engineering

SYS-048, Medical Device Academy’s Usability Procedure, is compliant with IEC/ISO 62366-1 (2015). The procedure was authored by Research Collective. The procedure includes a template for conducting summative (validation) usability testing. We have also updated our design plan template to include usability testing elements.

About your human factors testing webinar instructor

Bryant Foster Human Factors Testing Webinar

As Vice President of Human Factors and User Experience for Research-Collective, Bryant guides human factors efforts for medical device manufacturers, pharmaceutical companies, automakers, consumer product manufacturers, and more. Bryant has guided surgical instruments, combination products, home-use devices, and OTC products to FDA clearance or approval. Bryant’s automotive research experience includes in-vehicle infotainment systems, automated driving systems, and audio/visual navigation tools. Visit the website


2 thoughts on “Human Factors Testing Webinar”

  1. Hello, what is your recommendation for training/certification to become an SME in Usability/Human Factors/Clinical Engineering?

    1. Robert Packard

      Anyone can issue a certificate, but to my knowledge there is no accreditation process for human factors or usability that is globally recognized. There are several well-known training courses on IEC 62366-1 that you can take, and many of those courses will issue a training certificate when you complete the course. We are the in the process of building our own course. The webinars currently planned are listed on our webinar page, but the things that you need to look for in a “certification” course include the following:

      1) Scope covers the international standard (IEC 623661-1)
      2) Multiple instructors are experts on the topic and have practical experience
      3) Includes significant number of continuing education credits (i.e., 8+ hours)
      4) Practical exercises teach you how to create documents and fill-in templates
      5) Formative quizzes assess training effectiveness throughout the course
      6) Interactive elements simulate actual usability testing
      7) Summative exam concludes the course

      None of this is required, but that would be my personal wishlist.

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