Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Date : 25th September 2019 to 25th September 2019

Place : United States, Newark

Website :http://bit.ly/2kFOHBH

Contact Person:+1-(510)-868-1040

Description:

OVERVIEW 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. LEARNING OBJECTIVES User error versus use error Use related hazards and risk analysis User profiles Use scenarios Step by step human factors program development Validation WHY SHOULD YOU ATTEND The FDA will only approve devices 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 "user error," which means that it's how the product is used and not human error that is considered by the FDA to be a device nonconformity. As a result, human factors should be considered in the design process, and the burden is now on the device designer to create an "idiot proof" product. Human Factors Usability Testing is an analysis of how people interact with medical devices. In this session, expert speaker Edwin Waldbusser will explain 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. The various types and methods of human factors analysis will also be explained. This process conforms to the new ISO 62366 standard and the 2016 FDA guidance relating to it. AREAS COVERED The need for understanding and optimizing how people use and interact with technology Definitions: Use scenario, task, critical task 2016 FDA Guidance on applying human factors and usability engineering to medical devices Usability plan Use specification Usability hazard analysis Use-related hazards User interface specification User interface evaluation plan Preliminary analysis and evaluations Evaluation methods Analytical methods Empirical methods Verification and validation Human factors report WHO WILL BENEFIT? Development Engineers Production Management QA/QC Personnel Software Developers Usability engineers Risk managers Design Engineering Managers SPEAKER Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patients). He has been consulting 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. For more detail please click on this below link: http://bit.ly/2kFOHBH Email: [email protected] Tel: +1-(510)-868-1040

Human Factors Usability Studies Following ISO 62366 and FDA Guidance will be held in Newark,United States on date 2019-09-25

---

Deadline for abstracts/proposals : 25th September 2019

Keynote Speakers :

Venue :Online

Check the event website for more details.