DUBLIN–(BUSINESS WIRE)–The “Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance” webinar has been added to ResearchAndMarkets.com’s offering.
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.
Who Should Attend:
Engineer
Engineering management
Quality assurance
Regulatory
Key Topics Covered:
User error versus use error
Use related hazards and risk analysis
User profiles
Use scenarios
Step by step human factors program development
Validation
For more information about this webinar visit https://www.researchandmarkets.com/r/p6ange
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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