Human Factors and Usability Studies following ISO 62366 and the new FDA Guidance
- Speaker:Edwin Waldbusser
- Product Code:GRC-90202
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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 a more effective and safe to use product.
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 (2016) FDA Guidance.
Areas of Discussion:
- User error versus use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step by step human factors program development
Who will benefit:
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
Instructor Profile: Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting both in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.