Webinars > All COMPLIANCE Categories > Compliance Courses Webinars How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance WebinarIn this webinar speaker will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. Course Description/AgendaHow to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance Overview:
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Who Will Benefit:
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 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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