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Medical Devices

Global Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China Landscape

Wednesday, May 14, 2025
10:45 - 11:45 CEST
Location: Studio 211 + 212 (level 2)
Learning Level: Intermediate
Description: Welcome participants to the session, emphasizing the increasing importance of usability studies and human factors engineering in pre-market submissions, technical files drafting and regulatory process for US FDA, EU notified bodies and China NMPA. Highlight the pivotal role that regulatory professionals play in collaborating with various entities to ensure successful planning and implementation of these studies while considering compliance and regulatory strategy across diverse markets.
1. Overview of the increasing importance of human factors studies in the US, EU, and China
2. Similarities and differences between the US, EU, and China approaches
3. Case studies illustrating successful study designs and submissions in these regions
4. Practical tips for integrating usability studies into pre-market submissions
5. Considerations for global submissions and implementation of a global regulatory strategy, encompassing the US, EU, and China

Learning Objectives:

  • To provide a comprehensive understanding of the critical role of usability studies and human factors engineering in pre-market submissions and technical file reviews globally.
  • To equip regulatory professionals with knowledge on designing studies that align with compliance aspects and regulatory strategies in the US, EU, and China.
  • Practical tips for integrating usability studies into pre-market submissions