Value of a Human Factors Program

This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

The ISO 62366 is an “Consensus” Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
– Device Users
– Use Environments and User Interfaces
– Preliminary Analyses
– Exploratory HF/Usability Evaluations
– Hazard Mitigation and Control

We will look at the implication of HFE through Design Controls in the QSR:

  • Design input -includes “needs of the user and patient”
  • Design validation – “devices conform to defined user needs and intended uses and shall include testing of production units
  • Under actual or simulated use conditions. Design validation shall include software validation and risk analysis”[incl. use related risks]

Why You Should Attend:

This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3.

The implementation of a robust HF program will include both of these disciplines. Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted.

This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program.

Areas Covered in the Session :

  • HF Planning
  • Scope of Validation
  • Use Scenarios
  • Step by Step HF Program Development/li>
Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Engineering Departments
  • Production Departments
  • Device Software Developers

MD3170

Thomas Bento

Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for 17 years. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems, Regulatory consulting and SVP at Nihon Kohden America. Now he is Consulting for Philips Medical Systems. Through his experience he has found that the common thread that runs through the fabric of most Medical Device Manufactures is that more is better in order to meet regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance founded on understanding and addressing Risk Management Appropriately.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance