The Integration of Human Factors into Design Controls and Risk Analysis


This event qualifies for 12 RAPS


Human Factors/Usability testing is now a requirement.  Human Factors/Usability testing is good business and can be easily integrated into product design/development.  Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk.  The key to integrating Human Factors is to understand the activities involved throughout the product development cycle and the corresponding design controls.  These activities will be covered with the opportunity to implement on a real world problem/device.  In addition, the appropriate documentation and content will be covered so that a full picture of the integration can be understood. Differences between European and US standards will be covered as required.


Why should you attend?

Do you feel that Human Factors slows the time to market and increases costs of your products?  Do you feel that Human Factors documentation is foreign and cumbersome?  If you have answered "yes" to these two questions then you need to find out that the correct answer is quite the opposite.

Human Factors/Usability testing is now a requirement.  Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk.

Areas Covered in the Session:

  • Human Factors
  • Risk Management
  • uFMEA
  • Human Factors Testing
  • Design Controls
  • Human Factors and Project Management
  • Human Factors Documentation
  • FDA and CE Mark

Who Will Benefit:

  • QA Managers
  • Risk Managers
  • Product Managers
  • Project Managers
  • Device Engineers

Speaker and Presenter Information

Virginia A. Lang
Principal and Founder, HirLan, Inc. and HirLan International SA 

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center.  She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. 

These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA.  Her research dealt with cognitive factors that differentially affect the characteristics of visual displays.  Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

 

Expected Number of Attendees

50

Relevant Government Agencies

Dept of Education


This event has no exhibitor/sponsor opportunities


When
Thu-Fri, May 26-27, 2016, 9:00am - 6:00pm


Where
TBD
Washington, DC 22202


Website
Click here to visit event website


Organizer
GlobalCompliancePanel


Contact Event Organizer


Join the event conversation:
@gcpanel
#riskmanagement


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