How to Conduct a Human Factors - Test following ISO 62366 - 2017
- Start Date:
- Thursday, 13 April, 2017
- End Date:
- Thursday, 13 April, 2017 11:00am
- Health & Nutrition
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 ParticipantsTest ProcedureQualitative Success CriteriaChoice of Tasks to ValidatePost Test Participant Inquiry Who Will Benefit:EngineerEngineering ManagerRegulatory PersonnelQA 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: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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