Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.

This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.

This audio conference covers:

• The importance of human factors testing
• Key elements to the human factors design cycle
• When to perform human factors testing
• How to perform human factors testing
• Reporting the results of human factors test data

About the speaker:

William Mandel graduated from U.C.L.A and has worked in technology development for over 20 years. He has worn a variety of hats through his career. As an engineer, he understands the inner workings of devices and the product design and development process. As a team leader, William has an expanded understanding of the scope and magnitude of bringing a product to market. In the crucial role of engineering manager and as VP of Product Development, he sharpened his skills in managing a multitude of projects, people and budgets. William has a wide range of accumulated experience in various fields: medical instrumentation, software and hardware development, business owner and entrepreneur, and freelance consultant. These different roles have enhanced his understanding of design, development, marketing, sales, production, and distribution. William recently obtained his MBA.

Who should attend?

• Project Managers and Team Leaders
• Regulatory Affairs Professionals, Directors, and Managers
• Regulatory Specialists and Advisors
• Product Managers
• Human Factors Engineers
• Usability Engineers
• Engineering Managers
• Principal Engineers
• Senior Engineers
• QA Managers