Human factors testing webinar - "How to pass human factors validation"

Adam Shames presented a free webinar on the topic of “How to pass Human Factors Testing” for 510k submissions on September 6, 2017.

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When is the human factors testing webinar?

The human factors testing webinar, “How to pass human factors validation,” was presented live by Adam Shames on Wednesday, September 6, 2017. It’s free to register as long as you ask Adam a question. As new questions are submitted we will create blogs to answer your questions and add the questions to our 510k FAQs page.

Contents of human factors testing webinar – “How to Pass Human Factors Validation”

This webinar covers how to structure a human factors program from product conceptualization through design controls in order to pass a human factors validation study on the first attempt.
Participants in the webinar can expect to learn about the following key characteristics about Human Factors Engineering (HFE):
  • The regulatory imperative of HFE is focused on use-related harm, but HFE has many other uses.
  • HFE is an R&D activity, not a documentation activity.
  • It’s highly scalable; very few HFE programs are alike.
This webinar answers the following questions:
  • Do all 510k submissions require Human Factors Testing? 
  • Can Human Factors Testing be completed outside the US?
  • What kind of human factors testing is required for a standalone software device?
  • If our device is for aesthetic purposes, and has no potential for harm, is the human factors requirement still applicable?
  • More questions may be added this list as they are submitted. 
In addition to answering your submitted questions, this webinar will cover parts of the following standards, guidance, and technical information reports:
  • IEC 62366-1 & IEC 62366-2
  • HE 75, Human Factors Engineering – Design of Medical Devices
  • ISO 14971, Application of Risk Management to Medical Devices
  • Applying Human Factors and Usability Engineering to Medical Devices – FDA
  • Human Factors Studies & Related Clinical Considerations in Combination Product Design & Development – FDA
  • TIR 59, Integrating Human Factors into Design Controls

The webinar was presented live using Zoom, but we were unable to record this session. Registrants will receive a link to download a copy of the slide deck and notes kindly shared by one of the people that were able to participate in the live session. We will try to record the session at a later date. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.

What Standards does the FDA Recognize for human factors?

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

You might also be interested in the numerous articles Adam’s firm has published.

About your human factors testing webinar instructor

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Adam is a human factors expert. He has an MBA in International Business from the Fox School of Business and Management at Temple University and a BS in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world.He has also been the principal investigator on numerous successful IRB reviewed studies. Visit his website


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