Human factors standards for medical devices design are an integral part of new product development. These standards have gained in importance recently. This is mainly due to the increased realization that medical errors, deaths and unsafe events in health care are attributable to human errors. Human factors standards at present mainly relate to human device interface, physical environment and cognitive aspects of device users. The organizational setting plays a crucial role in medical device operation. Medical devices mediate health-care interventions. Organizational settings typically dominate health-care offering. An interaction of these aspects means that organizational factors in medical design standards become significant. This article analyzes organizational factors that need consideration in medical device design standards and standards development organizations. © 2010 Macmillan Publishers Ltd.