This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
The ISO 62366 is an “Consensus” Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
– Device Users
– Use Environments and User Interfaces
– Preliminary Analyses
– Exploratory HF/Usability Evaluations
– Hazard Mitigation and Control
We will look at the implication of HFE through Design Controls in the QSR:
- Design input -includes “needs of the user and patient”
- Design validation – “devices conform to defined user needs and intended uses and shall include testing of production units
- Under actual or simulated use conditions. Design validation shall include software validation and risk analysis”[incl. use related risks]
Why You Should Attend:
This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3.
The implementation of a robust HF program will include both of these disciplines. 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.
This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program.
- HF Planning
- Scope of Validation
- Use Scenarios
- Step by Step HF Program Development/li>
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- Production Departments
- Device Software Developers