Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance

    /Edwin   /Waldbusserspeaker of Training Doyensinvite
    Speaker: Edwin Waldbusser
    Date: Tuesday, February 12th
    Time: 01:00 PM EST | 10:00 AM PST


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    Duration: 60 Minutes
    Product Code: 50717
    Level: Intermediate

OVERVIEW

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 medical device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors/usability analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

WHY SHOULD YOU ATTEND

The FDA will only approve devices which are so designed 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 device nonconformity because human factors/ usability should be considered in the design process. The burden is on the device designer to follow usability studies, perform medical device risk analysis and create an “idiot proof” product.

Handouts are use specification template, user interface evaluation template, and usability validation control form

AREAS COVERED

  • Difference between user error and use error 
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • validation

LEARNING OBJECTIVES

Learn about use related hazards and risk analysis in medical devices and how to create a device that complies with the FDA guidance. Know how to assess human factors/usability in the design process and maintain compliance with ISO 62366.

WHO WILL BENEFIT

  • Engineer
  • Engineer management
  • Quality assurance
  • regulatory

SPEAKER

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 9 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.

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