August 24, 2015 - August 25, 2015 | Bangalore

9:30 am to 5:00 pm

To understand the hazards related to the use of a medical device it is necessary to have a complete and accurate understanding of how the device will be used. Human Factors Engineering (HFE) and Usability Engineering (UE) are all about understanding and optimizing how people interact with devices and technologies. This comprises three major components: users, environment in which the device is used, and user interface of the device.

UL is organizing a 2-day workshop that gives a comprehensive overview of human factors as related to medical devices. The workshop covers  regulatory requirements of FDA and EU, and the processes of applying human factors in design controls during the design of a medical device. There will be hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

Key Topics Covered

 

  • Review of current regulations and standards (focusing on IEC 62366)
  • Differences between IEC requirements and FDA expectations
  • Components of a complete HFE design history file
  • Defining the users, use scenarios, use environment, and user requirements
  • Writing a usability specification
  • Preparing a UI validation plan
  • Identifying use-related risks
  • Designing safe, effective, and satisfying user interfaces
  • Conducting usability tests
  • Sample usability test demonstration

Speakers
The workshop will be led by Jon I. Tilliss and Erin M. Davis, managing human factors specialists at Life & Health UL LLC Wiklund R&D. Tillis has a B.S. in mechanical engineering from Tufts University and M.P.S. in Digital Media and Interactive Design from Northeastern University. Davis has a B.S. in biomedical engineering from Marquette University and M.S. in Human Factors Engineering from Tufts University.

Who Should Attend?
UL recommends this course for professionals who already have a basic understanding of the framework of quality management systems, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the quality system regulation and design controls.
Registration Fees: Rs. 25,000/- + Service taxes

For more information, contact lavanya.pavan@ul.com or call  +91 96638 40174, +91 80 41384434