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 minimise 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.   

In this presentation we will review: 

• Regulatory Landscape for Clinical Software Solutions 

• Using a Human Factors Approach in clinical software development 

• Challenges and Considerations 

• Case Studies