Online Webinar 2019 - Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Overview
This training program will examine how 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 document.
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
Objectives of the Presentation
User error versus use error
Use related hazards and risk analysis
User profiles
Use scenarios
Step by step human factors program development
Validation
Who will Benefit
Development Engineers
Production Management
QA/QC Personnel
Software Developers
Usability engineers
Risk managers
Design Engineering Managers
Why Should you Attend
The FDA will only approve devices 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," which means that it's how the product is used and not human error that is considered by the FDA to be a device nonconformity. As a result, human factors should be considered in the design process, and the burden is now on the device designer to create an "idiot proof" product.
Human Factors Usability Testing is the analysis of how people interact with medical devices. In this session, expert speaker Edwin Waldbusser will explain 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. The various types and methods of human factors analysis will also be explained. This process conforms to the new ISO 62366 standard and the 2016 FDA guidance relating to it.
speaker
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.