Human Factors and Usability Studies following ISO62366 and the new 2016 FDA Guidance

Product Id : FDA04
Instructor : Edwin Waldbusser
Jan 17, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT

Description

Webinar Description

This webinar training session focuses on examining how the human factors/ usability provides a base for analysis on people’s interactions with the medical devices. 

It aims at explaining the process of carrying out rigorous human factor studies throughout the process of design, integration with the risk analysis of the device and validation of effectiveness of the studies. In addition, the speaker will also elaborate and give explanations on the different methods and types of human factor analysis that adhere to the newly introduced ISO 26366 standards as well as the new FDA guidance text.

Key Session points:

  • Risk analysis and user related vulnerabilities
  • User errors vs. use errors
  • Use scenarios
  • User profiles
  • Procedural human factors program development

Why you should attend:

FDA is going to approve only those devices that are designed to safeguard people from harming themselves accidentally, even in the event that they mishandle the device. As such FDA has changed the phrase “user error” into “use error” just to show that the use error comes as a result of device non-conformity since human factors ought to be considered during the device design process. 

Therefore, this webinar is going to focus on user error vs. use error, risk analysis and other detrimental effects related. You will also be enlightened on various methods and types of human factor analysis.

Who should attend:

  • Production management
  • Development engineers
  • Software developers
  • Development engineers
  • QA/QC Personnel



Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.


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