Medical devices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medical devices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in...

Hypothermia is a state in which the temperature of a human body is below the normal temperature, with the onset of the hypothermic state commonly regarded as 36°C. This state may be encountered due to exposure to a very cold environment in the outdoors or, surprisingly, in a hospital operating...

Study Design. Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain. Objective. To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost....

Purpose – The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way. Design/methodology/approach – When a company...