Human factors is the science of interactions between users and a product user interface. Originally the field evolved as a blend of industrial engineering and psychology. In the past twenty years, medical device regulations have begun to incorporate the requirement for validating that design controls, training, and instructions for use are adequate to prevent use errors. There is a standard for this, IEC 62366-1, but companies typically validate the risk controls they implement by conducting a small summative usability study involving 15 people. That isn't enough, and post-market surveillance is necessary to make sure your risk controls are adequate. PMS is also a requirement of ISO 14971--the risk management standard. Therefore, human factors should be part of PMS.
If you aren't familiar with the human factors process for medical devices, here's an article on the topic:
medicaldevicea...
If you aren't familiar with the post-market surveillance process for medical devices, here's a link for a webinar and a procedure for post-market surveillance (PMS):
medicaldevicea...
medicaldevicea...
9 сен 2024
