This course offers a concise overview of Human Factors (HF) in medical device design, focusing on its integration across all stages of product development, from concept to post-market surveillance (PMS). Participants will explore the essentials of Human Factors Engineering (HFE), including its role, key deliverables, regulatory standards, and the return on investment (ROI) in product development. The course also covers formative evaluation methods, such as task analysis and usability testing, which are crucial for shaping product usability. Finally, the course highlights Human Factors Validation Testing (HFVT) as part of design validation, emphasizing regulatory compliance and best practices. The key takeaway is a solid understanding of HF deliverables necessary for regulatory approval and effective product development.

Over the course of (4) hours, the attendee will be able to:

• Identify the role of Human Factors Engineering (HFE) in medical device design and articulate its impact on product usability and regulatory compliance.
• Apply formative evaluation methods, including task analysis and usability testing, to improve product design and document these efforts within the usability engineering file.
• Execute Human Factors Validation Testing (HFVT) as part of design validation and ensure compliance with regulatory requirements by avoiding common submission errors.

• Human Factors Engineers
• Quality Engineers
• Systems Engineers
• Regulatory 
• Usability 
• Interaction Designers
• Project Managers