How to conduct a successful and FDA-compliant Human Factors/Usability study for your medical device

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, May 03, 2018
60 minutes
Product Description

Learn to Validate a Device’s Safety and Effectiveness

Human factors and usability engineering is the understanding of how people interact with technology—and how the user interface design affects that interaction. But pleasing the user isn’t your only concern when developing a medical device. You must also satisfy the Food and Drug Administration (FDA) that you’ve created a device that’s safe and effective—by following a rigid set of guidelines for product testing.

Join medical device consultant Edwin Waldbusser as he explains the FDA validation process in detail—and everything you must do to conduct a compliant human factors/usability study. Waldbusser will examine the procedure described in ISO62366 and the 2016 FDA guidance. Human factors/usability validation is very different from device validation, and Waldbusser has the background and training to explain this tricky part of the device development process.

For instance, after attending this event, you’ll understand that success criteria for human factor/usability validation are qualitative rather than quantitative (as they are in device validation). Claiming success because, for example, 95 percent of test participants did not commit a user error, is not valid. And showing 100 percent positive test results is not sufficient. Waldbusser will explain qualitative success criteria, the required number of participants, the Usability Validation Tracking Matrix, and everything else you need to succeed in this critical step of product development.

Session Highlights

Here is a taste of what you will uncover:

  • Required numbers of participants
  • Qualitative success criteria
  • Choice of tasks to validate
  • Post-test participant inquiries
  • The Usability Validation Tracking Matrix (given as handout)
  • The Validation Protocol (given as handout)
  • The Validation Test Results Report (given as handout)

Who Should Attend

  • Development engineers
  • Production management
  • QA/QC personnel
  • Software developers
  • Engineering management

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Edwin Waldbusser

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...   More Info
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