Human Factors and Usability Studies following ISO 62366 and the new FDA Guidance

Product Id : FDA126
Instructor : Edwin Waldbusser
Jun 12, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Download Conference Material

Download Here (Password Needed)



Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance.

Why Should You Attend:

The FDA will only approve devices which are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “use error”. This means that use error is considered by the FDA to be a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an “idiot proof” product.

Learning Objectives:

  • User error versus use error
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Use scenarios
  • Validation

Session Highlights:

  • The changes to ISO 62366 standard
  • The changes to new FDA Guidance
  • The process of conducting rigorous usability and human factors studies during
    • the product design process 
    • integrating it with the device risk analysis & design process
    • validating the effectiveness of the studies
  • Common Mistakes and how to avoid them
  • Step by step human factors program development

Who Will Benefit:

  • Engineering Personnel
  • Production Management
  • QA/ QC Personnel
  • QA/ QC Personnel
  • Management Team
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.

Available Options