The "The Value of a Human Factors Program" conference has been added to ResearchAndMarkets.com's offering.
This seminar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/usability program.
This year FDA published their priority list for the completion of their Guidance documentation. This FDA activity gives us inspection and enforcement insight into the priorities within the agency. Human Factors was in the #3.
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 seminar will help to sort through the confusion of the FDA Guidance and ISO standards and help meet regulatory expectations by demystifying the tasks necessary to build a robust Risk based HF 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
Key Topics Covered:
- HF Planning
- Scope of Validation
- Use scenarios
- Step by step HF program development
For more information about this conference visit https://www.researchandmarkets.com/research/xg5vk3/2_day_seminar?w=4
View source version on businesswire.com: http://www.businesswire.com/news/home/20180117005715/en/
