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.
Why You Should 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. This session 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 new FDA Guidance document.
Additional Handouts:
– Use specification template
– User interface evaluation template
– Usability validation control matrix form
Areas Covered in the Session :
- The need for understanding and optimizing how people use and interact with technology
- Definitions: Use scenario, task, critical task
- Latest 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 Should Attend:
- Development Engineers
- Production Management
- QA/QC Personnel
- Software Developers
- Usability engineers
- Risk managers
- Design Engineering Managers
MD3390
