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