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.
Why should you Attend?
When implementation of the results of a Human Factors/ Usability study are successful, human factors (HF) validation can be very straightforward. It is like checking off the boxes on a study protocol. But if all the pieces of implementation of the results of a Human Factors/ Usability study do not come together as planned, however, HF validation can be a complicated endeavor.
In this webinar we will try and make it easy to have a straightforward implementation and explain the basic difficulties faces. Below would be a few of the questions this webinar will try to answer.In the case of usability/human factors study, questions like:
Who will benefit?
This webcast will be of a valuable assistance to the below audience
ISO 62366, FDA Guidance, Validation Test, Human Factors, FDA, Medical Device, Device Validation, Risk and Validation Activities, Sample Size Requirements, Engineers, QA, QC
Ed 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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