How to Conduct a Human Factors - Test following ISO 62366 - 2017

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.

Why should you Attend:
We will explain 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. we will describe how to do this.

Areas Covered in the Session:
Required number of Participants
Test Procedure
Qualitative Success Criteria
Choice of Tasks to Validate
Post Test Participant Inquiry

Who Will Benefit:
Engineer
Engineering Manager
Regulatory Personnel
QA

Speaker Profile:
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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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