Human Factors for Medical Devices in Japan: What Global Manufacturers Need to Know
As Human Factors Engineering (HFE), commonly referred to as Usability Engineering (UE) in Japan and the EU, becomes a core pillar of safe and effective medical device design worldwide, international manufacturers may find themselves asking, “How is usability evaluated in Japan?” In the US, the FDA requires a formal HFE/UE report* for most Class II […]