Human Factors/Usability Studies Following ISO 62366 and the New FDA Guidance - Webinar - ResearchAndMarkets.com

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The "Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance" webinar has been added to ResearchAndMarkets.com's offering.

Metadata
Provider: 
Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Friday, December 2, 2022
Information
Tags: 
Medical Devices, Health, ISO, FDA, Medical device
Organisation: 
RESEARCH AND MARKETS
Summary
Key Points: 
  • 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 "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

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