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 Should You Attend:
Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required number of validation participants from each 'distinct user population'. We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. We will describe how to do this.Areas Covered in the Webinar:
- Required number of participants
- Qualitative success criteria
- Choice of tasks to validate
- Post test participant inquiry
- Use scenarios
- Step by step human factors program development
- Validation
Who Will Benefit:
- QA/QC Personnel
- Manufacturing
- Development Engineers
- Production Management
- Software developers
- Engineering management
Course Provider
Edwin Waldbusser,
