Design and Evaluation of Electronic Instructions for Use (eIFUs)

Common human factors engineering (HFE) standards and guidance documents (such as IEC 62366-1, FDA’s HFE guidance, HE75) do not yet cover or provide specific advice on evaluating electronic instructions for use (eIFU). However, in other documents, less commonly referenced in the human factors engineering process, regulators have set specific eIFU expectations that also impact HFE activities such as labeling validation efforts.

Our goal is to provide attendees with sufficient content that enables them to:

• Understand the regulatory perspective(s) (e.g., FDA, relevant EU Regulations) on eIFUs.
• Understand the implications for HFE practitioners regarding the design and evaluation of eIFUs.
• Learn about various design considerations (e.g., hierarchy, navigation, contrast) that will ensure eIFUs are clearer, safer and easier to use.

About the presenters:

Yvonne Limpens, managing human factors specialist, Emergo by UL

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device, pharmaceutical and laboratory equipment industries. She leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Limpens holds a B.S. in Industrial Design and an M.S. in Human Technology Interaction, both from Eindhoven University of Technology (NL).

Oliver Cook, senior user interface designer, Emergo by UL

Oliver Cook is a user interface designer with Emergo by UL’s Human Factors Research & Design (HFR&D) team. He has been with the team since 2017. He has experience supporting product design, user instructions and user interfaces. Cook has experience in early-stage user research and usability testing. In addition, he helps clients develop key Human Factors Engineering (HFE) documents for their design history files, including use-related risk analyses, and advises clients on how to apply HFE during product development to meet regulators’ expectations.