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.Agenda
- User error versus use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step by step human factors program development
- Validation
Who Should Attend
- Engineer
- Engineering management
- Quality assurance
- Regulatory
