Conduct A Human Factors/ Usability Validation Test To Pass - ISO 62366
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Course Description:
- The procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation test
- Learn how human factors/ usability validation is very different from device validation
- Define 62366 regulatory and/or design control deliverables
- What criteria do you use to identify critical tasks from your risk assessment
- We will also discuss documentation requirements
- Also about if there is a timeline to comply with FDA human factors guidelines
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:- Should risk and validation activities be covered separately
- When should validation of the safety and effectiveness of the use of the device be conducted
- For non-complex devices usability studies, what are sample size requirements
- What is the FDA required number of validation participants from each Distinct User Population
- How to choose the tests to be conducted and the studies that must be completed prior to the actual validation test
- The post test participant inquiry is critical to validation success
Areas Covered:
- Required number of participants
- Qualitative success criteria
- choice of tasks to validate
- Post test participant inquiry
Who will benefit?
This webcast will be of a valuable assistance to the below audience
- Engineers
- Engineering Management
- Regulatory Personnel
- QA/ QC personnel
Registration Options
Tags
ISO 62366, FDA Guidance, Validation Test, Human Factors, FDA, Medical Device, Device Validation, Risk and Validation Activities, Sample Size Requirements, Engineers, QA, QC
Speaker Details
Edwin Waldbusser
Medical Device Consultant
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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