Conducting Usability Tests in China for NMPA: An Overview of Considerations Based on Past Learnings

Webinar attendees will come away with a greater understanding of how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.

Learning objectives:

• An introduction to NMPA’s HFE guidelines
• An overview of the HFE requirements outlined in the NMPA’s HFE guidelines
• Considerations and best practices on conducting usability tests in China for NMPA based on past learnings

About the presenters:

Ken Yoshida

Ken Yoshida is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Tokyo, Japan. He has been with the team since 2015 and specializes in medical device technology. Yoshida occasionally delivers public seminars to advocate the importance of applying HFE to medical device development in Japan. Yoshida holds a bachelor’s degree in computer science and psychology from Indiana University Bloomington, a Master of Education in community counseling from Loyola University Chicago, and a doctorate in Kinesiology specializing in human factors from the University of Minnesota.

Yvonne Limpens

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