Demystifying the FDA’s Human Factors Guidance

The FDA’s human factors guidance can be a complicated document, especially if you are:

  • A new professional in the field of human factors?
  • A project manager looking for guidance on the Food and Drug Administration’s (FDA) validation test requirements?
  • An engineer in the medical field who has heard about the FDA human factors guidance but doesn’t have a clear understanding of them?

Reviewing the guidance can feel overwhelming for the first time. However, there are professionals with years of experience who can help guide you through the process. One of those experts is VP of Research and Design at Research Collective, Bryant Foster. With over five years of experience helping companies successfully prepare for the FDA’s human factors validation test, Bryant is passionate about helping others understand the process.

Recently, Greenlight Guru hosted a webinar with Bryant on the topic of demystifying the guidance. In the webinar, Bryant defines common terms useful for all human factors professionals, breaks down the FDA guidance into three steps, and offers suggestions for following up after your device has been approved by the FDA.

This one hour webinar is a great learning tool if you’re looking for clarity on the FDA’s human factors guidance. Whether you’re new to the field or you’re looking to refresh your knowledge, Bryant offers a great overview.

“It’s easy to make things hard. It’s hard to make things easy’”

–Alphonse Chapanis

Click on the image below to view the pre-recorded webinar or follow this link: https://www.greenlight.guru/webinar/human-factors-fda-success

Screen shot of demystifying the FDA's human factors guidance webinar.

If you have additional questions about the FDA human factors guidance review this post.

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