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

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Category fda guidelines, fda medical device, FDA compliance seminar, fda quality management system, quality assurance, regulatory affairs, healthcare regulatory compliance trainings, regulatory affairs manager, css validator, 2017 online trainings

Deadline: April 12, 2017 | Date: April 13, 2017

Venue/Country: Fremont, U.S.A

Updated: 2017-02-24 18:53:42 (GMT+9)

Call For Papers - CFP

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.

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Compliance4All DBA NetZealous,

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