Demystifying The FDA's Human Factors Guidance

In 2016, the FDA finalized its human factors guidance for medical devices.

This guidance document cleared up some of the uncertainty about how manufacturers should implement human factors into their product development process.

However, due to the wide diversity of medical devices manufactured today (auto-injector vs. infusion pump vs. robotic surgical system etc.), manufacturers often struggle to understand how the guidelines apply to their own specific device(s).

This webinar will break down FDA’s human factors guidance into a list of actionable steps.

In this free 60 minute webinar our presenter Bryant Foster, VP Research & Design at Research Collective, will describe proven strategies that will help manufacturers: (1) improve their time to market and overall design through early implementation of human factors and (2) pass their human factors validation test for FDA clearance.

Watch the webinar

Specifically, you will learn:
      • An understanding of usability testing and its role within the field of human factors
      • How to improve overall product design and speed to market by implementing human factors into design controls
      • Strategies to pass a human factors validation test on the first attempt
      • The importance of including in their human factors strategy all of the tasks impacted by the device use (device setup, instructions for use, cleaning, disposal, etc.)
      • The first step a manufacturer should take after receiving a deficiency letter that mentions a lack of human factors
      • The future of post-market usability surveillance
Who Should Attend?
      • Medical Device Executives
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management
      • R&D Engineers and Management

Hosted by

Presenter: Bryant Foster

VP Research & Design, Research Collective

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Research Collective

Research Collective is a full-service human factors and user experience research firm. We do early design, formative and validation studies for medical device companies seeking better designs and FDA clearance. We believe rigorous, human-centered design is a critical component to the success and to the safety of a product or procedure. 

Our team of researchers have MS and PhD degrees in human factors and cognitive science, with significant experience in research design, fielding, advanced statistical analysis and reporting. We've worked with medical device clients, large and small, including: Bard, BD, Medtronic, Mayo Clinic, SynCardia, Everist Health and Intuitive Surgical. Click here to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

Featured In