If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file - or worse, your actual design - and resubmit it for another chance at FDA approval. Learn how to make certain it's the right time for your human factors study.The post Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps appeared first on Mindflow Design.
MindFlow Design is a California-based medical product design firm that provides services such as engineering and usability testing for the healthcare industry.