Human Factors Engineering 2014

Topics

• The flow of requirements starting from the initial documentation to usability validation
• The versions of IEC 62366 and its status in the US, EU, and Canada
• The contents of the Usability Engineering file
• The links between the Risk Management standard (ISO 14971:2007) and usability engineering
• The flow of information and the parallels to IEC 62366:2007
• The FDA-CDRH draft guidance on usability engineering

Who should Attend

• Regulatory Affairs Managers
• Quality Managers
• Design Engineers
• Design Engineering Managers
• Complaint and Reporting Specialists