2014 - Human Factors Engineering

DESCRIPTION
Usability Engineering, (Human Factors Engineering) is an essential part of a device development program. In fact, a major issue arises when a device works correctly, but is used incorrectly. This is called “use error” and can cause harm to a patient or user.
If you have not implemented a Usability Engineering program, your design control system is not adequate. You open yourself up to audits, inspections, and product liability issues. The program will help you ensure your devices are used correctly and that ISO 14971:2007 risk reduction using information for safety is effective.
The solution is to implement IEC 62366:2007 which explains how to create a Usability Engineering program. This international standard is recognised by FDA-CDRH and harmonized to the MDD. In addition, FDA-CDRH has a draft guidance that explains their approach, which aligns with IEC 62366.
This webinar walks you through the Usability Engineering process and helps you implement an effective system that aligns with design validation including risk management.
It also includes the recent amendment to the standard that covers User Interfaces of Unknown Provenance (UOUP). This approach will help you deal with legacy device issues.
Areas Covered in the Session:
The versions of IEC 62366 and its status in the US, EU, and Canada
The flow of requirements starting from the initial documentation to usability validation
The links between the Risk Management standard (ISO 14971:2007) and usability engineering
The contents of the Usability Engineering file
The FDA-CDRH draft guidance on usability engineering
The flow of information and the parallels to IEC 62366:2007
Who Will Benefit:
Quality Managers
Regulatory Affairs Managers
Design Engineering Managers
Design Engineers
Complaint and Reporting Specialists
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance