Tuesday, November 7, 2017 at 8:30 AM GMT
Thursday, November 9, 2017 at 4:30 PM GMT

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Hilton Hotel Cambridge City Centre 
Downing Street
Cambridge CB2 3DT
United Kingdom

Driving Directions 


Sean Warren 
The Moon on a Stick Ltd 

Essential Human Factors for Medical Devices 

This 3-day event will inform you of the Regulatory requirements of FDA, more specifically the interpretation from the Centre for Devices and Radiological Health (CDRH) Human Factors Pre-Market Review Team, as they relate to human factors and the process of applying human factors in design controls and the FDA approval process during the design of a medical device. 

We’ll discuss the basic foundation for applying human factors, including: 

  • The application of user models
  • Task analysis
  • Analysis of use errors
  • How task analysis forms the basis for planning human factors efforts and risk assessment
  • Along with a review of human factors activities: -Contextual inquiry
  • Heuristic evaluations
  • Formative studies
  • And Summative studies

We’ll cover relevant Human Factors standards, as well as Human Factors in the post-market arena. And there’ll be hands-on exercises as well as real-life case studies, illustrating the application of Human Factors to medical devices. 

In addition, there will be two specific faculty Q&A breakfasts where you can have your specific questions answered.