Description: Regulatory professionals are often responsible for compiling human factors data for regulatory submissions, even though they may not be human factors practitioners. Integrating human factors engineering at the beginning of the new product development process is key in enabling companies to efficiently conduct and document HF analyses throughout product development. This ensures robust HF data will be available when compiling regulatory submissions. In this session, regulatory professionals will learn the appropriate timing and requirements for key HF analyses to prevent costly and unnecessary post-submission delays. In addition, case studies will be presented for leveraging use-related risk analysis in lieu of conducting HF Validation testing.
Learning Objectives:
Develop the overall HF strategy by identifying the type and timing of HF analyses and testing required for submissions.
Coach their organization on how to integrate human factors into the product development and regulatory submission timelines to ensure success
Understand the importance of selecting stakeholders, both internal and external, to support the success of the project throughout the product development lifecycle.
