The Value of a Human Factors Program
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 Human Factors program.
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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:
Why should you Attend:
- 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]
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.
Areas Covered in the Session:
Who Will Benefit:
- HF Planning
- Scope of Validation
- Use Scenarios
- Step by Step HF Program Development
- QA/QC Personnel
- Software Developers
- Engineering Managers
Thomas is currently working as the Sr. Vice President of Quality & Regulatory Assurance at Nihon kohden America, manufacturers of Patient Monitors, Neurological and Cardiovascular devices.
He is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for close to 15 years. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems and as a regulatory consultant for small, medium and large Medical device manufactures.
Through his experience he has found that most Medical Device Manufactures feel that more is better to meeting regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance.