IMRIS, Inc. announced that the company has successfully completed the human factors study for the SYMBIS Surgical System - the comprehensive validation used to support the product's 510(k) submission to the U.S. Food and Drug Administration (FDA) on November 26, 2014. Human factors is the science of understanding how humans interact physically and psychologically with a device. For example, in aviation, an engineer can develop an instrument; however, if the engineer fails to account for how a pilot uses this instrument in the cockpit, then user errors may result even if the instrument did its job.

Over the past eight years, the FDA has been actively working with companies to apply the science of human factors to medical device development.