Human Factors Usability is the analysis of how people interact with medical devices and medical device risk analysis. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard.
Why Should You Attend:
The FDA will only approve medical 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.
Areas Covered in this Webinar:
User error versus use error
Use related hazards and risk analysis
Step by step human factors program development
Learn how to conduct Human Factors studies and integrate them into your design process
Who Will Benefit:
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
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