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ISO 62366 - How to Conduct a Human Factors

Event Details

ISO 62366 - How to Conduct a Human Factors

Time: April 18, 2018 from 10am to 11am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Feb 15, 2018

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Event Description

Overview:
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability 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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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