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Every department that has “ownership” of biomedical devices must designate one or more persons to be responsible for device control. Everyone that uses a biomedical device in the course of their work is part of the safety process too. Here's how Devices cannot be put into service until completion of an initial safety test and they cannot stay in service if they are past due for preventive maintenance...
Off label use as applied to medical devices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses. Beyond a use not being indicated, some off label uses may be expressly contraindicated as well as explicitly warned against. One example here is the currently controversial...
The article consists of a Powerpoint presentation on medical devices quality management systems. The areas discussed include: healthcare standards; key performance indicators; service performance; risk management; and device maintenance profile.
The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review-from device classification and clinical studies to the final marketing application-FDA's premarket requirements...
People living in areas of the world that are affected by disease, famine, or poverty could have their lives drastically improved by currently available electronic technologies, but the cost, complexity and/or limited operating environments of devices which employ these technologies can make it impossible or impractical for many of those in-need populations to actually acquire and make use of them...
People living in areas of the world that are affected by disease, famine, or poverty could have their lives drastically improved by currently available electronic technologies, but the cost, complexity and/or limited operating environments of devices which employ these technologies can make it impossible or impractical for many of those in-need populations to actually acquire and make use of them...
The article consists of a Powerpoint presentation on clinical software standards. The areas discussed include: standards in the NHS; acceptance testing; quality management; focus on risk management; performance standards; health care commission; standards in procurement; human factors; and medical devices
The Mobile Usability Lab (MU-Lab) is a tool developed by the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation (RERC-AMI) to study the accessibility and usability of medical devices by people with diverse abilities. The system includes a suite of data collection hardware components and a custom software interface to help coordinate problem identification and planning...
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