Ensuring Safe and Effective Device Design
Aqua Guard Allinone Corp facilitates the development of safe and effective product devices to meet the regulatory expectations. The Human Factors Engineering (HFE), also called Usability Engineering, ensures the development of safe and effective device design by identifying and appropriately mitigating risks associated with usability.
Define HFE process & level of effort
Aqua Guard Allinone Corp is implementing HFE process and plans for HFE activities
- HFE standard operating procedure and documents models
- HFE plan
Understand users & use environments
Aqua Guard Allinone Corp is Defining users, as to environments related to water purification systems and medical indications
- User research (field observations, interviews, questionnaires)
- Use Specifications document
Identify tasks & use- related risks
Aqua Guard Allinone Corp is Defining user interface and iteratively design and evaluate prototypes with users
- User Interface Specification document
- User Interface Design (incl. instruction for use, labelling, training materials)
- Formative tests (full process)
Define & evaluate design with users
Aqua Guard Allinone Corp is Defining user interface and iteratively design and evaluate prototypes with users
- User Interface Specification document
- User Interface Design (incl. instruction for use, labelling, training materials)
- Formative tests (full process)
Demonstrate safe & effective use
Aqua Guard Allinone Corp Demonstrating safe and effective use by intended users, evaluate residual risks and summarize all HFE activities
- Summative/HFE validation tests (full process)
- Use-Related Risk analysis update
- HFE summary report