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Human Factors-Usability Based on ISO 62366

4107
Duration : 60 Minutes

Edwin Waldbusser, Medical Device

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more


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.

This webinar will focus on the user error vs. use error aspects as well as use related hazards and risk analysis. It will also examine various types and methods of human factors analysis.

Course Objective:

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

Course Outline:

• User error versus use error
• Use related hazards and risk analysis
• User profiles
• Use scenarios
• Step by step human factors program development
• Validation

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Human Factors-Usability Based on ISO 62366


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