August 11, 2016 / by Tensentric

Tensentric HF Engineer Discusses FDA Released Updated Human Factors Guidance

Elise Edson, Senior User Experience & Human Factors Engineer, commented on the newly released human factors guidance. “Now that the FDA draft guidance is ‘final’, it gives Tensentric and our clients a lot more clarity on what’s required and expected for HFE. There was a lot of industry feedback!”

Read the full guidances here: Applying Human Factors and Usability Engineering to Medical Devices

In addition, you can listen to a Webinar on Human Factors to Ensure Safe & User-Friendly Product Designs. The date and time are being updated, so check the registration website for current info. This webcast will show the wealth of guidance and reference information, and how you can get information to your engineering, design and development team at the right place and right time. Included in the talk will be details about:

  • Standards from leading standards developing organizations such as Human Factors and Ergonomics Society (HFES), ISO, SAE, AAMI.

  • Guidance and standards from leading regulatory agencies such as FDA and FAA

  • Best practices and hottest HF titles from the world’s leading publishers including John Wiley & Sons, Taylor & Francis, IET, ITG

  • Critical data from ISO working groups, including ISO TC159/SC1 – Ergonomic Guiding Principles WG5 Ergonomic Process Standards