New FDA Guidance- Medical Device Human Factors Validation Testing Following ISO 62366

Product Id : FDA106
Instructor : Edwin Waldbusser
Feb 22, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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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 (2016) 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
  • Step by step human factors program development
  • Validation

Session Highlights:

  • The need for understanding and optimizing how people use and interact with technology
  • Definitions: Use scenario, task, critical task
  • 2016 FDA Guidance on applying human factors and usability engineering to medical devices
  • Usability plan
  • Use specification
  • Usability hazard analysis
  • Use-related hazards
  • User interface specification
  • User interface evaluation plan
  • Preliminary analysis and evaluations
  • Evaluation methods
  • Analytical methods
  • Empirical methods
  • Verification and validation
  • Human factors report

Who Will Benefit:

  • Engineering Personnel
  • Production Management
  • QA/ QC Personnel
  • Software Developers
  • 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.

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