Human Factors/Usability Based on ISO 62366

Instructor: Edwin Waldbusser
Product ID: 704496
  • 17
  • November 2016
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
November 17, Thursday 10:00 AM PST | 01:00 PM EST
Duration: 60 Min

One Dial In - Unlimited Participation in a conference / Meeting Room

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

Why Should You Attend:

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.

Areas Covered in the Webinar:

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

Who Will Benefit:

  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

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 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.

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