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University of Michigan Innovation Partnerships
University of Michigan Innovation Partnerships
Events

Human Factors Engineering in Clinical Decision Support (CDS) and Software as a Medical Device (SaMD)

October 10, 2023

Join us on Tuesday, October 10 at 3:30pm for Innovation Partnerships Software Thought-Leadership Series: Human Factors Engineering in Clinical Decision Support (CDS) and Software as a Medical Device (SaMD) where we take on specific questions related to the use of human factors engineering in healthcare.

The FDA recognizes the importance of human factors engineering in the design and development of medical devices, including clinical support software. Designing clinical tools around human factors takes into account human capabilities, limitations and characteristics to protect the wellbeing of people and to minimize the risk of design-induced human performance issues. The regulatory pathway for clinical support software can vary based on intended use, risk level and complexity of the software. Within these pathways, Human Factors data is an integral part of your product development and data to support your regulatory submission.

The discussion will be led by Shannon Hoste, Vice President of Agilis by Kymanox and Assistant Professor in the Quality Science Education program at Pathway for Patient Health.

Discussion will include:

  • Regulatory Landscape for Clinical Software Solutions
  • Using a Human Factors Approach in clinical software development
  • Challenges and Considerations
  • Case Studies

SOFTWARE THOUGHT-LEADERSHIP SERIES: HUMAN FACTORS ENGINEERING IN CLINICAL DECISION SUPPORT (CDS) AND SOFTWARE AS A MEDICAL DEVICE (SaMD)

Tuesday, October 10, 2023  |  3:30 pm  |   Webinar Registration Link

Please send questions to Tina Suntres, Assistant Director, Software, Content Licensing and Research Partnerships.