Medical Device Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

Thursday, Feb 15, 2018 at 1:00 PM to 2:00 PM EST

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Thursday, Feb 15, 2018 at 1:00 PM to 2:00 PM EST

 

Description:

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 quantatative 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 you should attend :

Following the implementation of the reults of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required number of validation participants from each "distinct user population". 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. handouts areusability validation tracking form,protocol form, and test results report form

Areas Covered in the Session :

Required number of participants
Qualitative success criteria
Choice of tasks to validate
Post test participant inquiry.

Forms:

Usability Validation Tracking Matrix
Validation Protocol
and Validation Test Results Report will be given as Handouts

Who Will Benefit:

Development Engineers
Production Management
QA/ QC personnel
Software developers
Engineering management

About Speaker:

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

Edwin Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

Event URL: http://bit.ly/2C10SLM

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