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Medical devices: US medical device regulation
Urologic Oncology: Seminars and Original Investigations, 2015Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting ...
Jonathan P, Jarow, John H, Baxley
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Expert Review of Medical Devices, 2005
This perspective provides a commentary on the quality of life improvements made available from advances in medical device technology. An opinion of the elements necessary to bring innovation into medical device research is offered. In order to enhance the output of medical device research, strong interactive links are needed between clinicians and ...
Boyle, Justin +4 more
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This perspective provides a commentary on the quality of life improvements made available from advances in medical device technology. An opinion of the elements necessary to bring innovation into medical device research is offered. In order to enhance the output of medical device research, strong interactive links are needed between clinicians and ...
Boyle, Justin +4 more
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Biomedizinische Technik/Biomedical Engineering, 2011
The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to patient safety due to missing or suppressed alarms are being reported. The purpose of this paper is to present results from a workshop titled "Too many alarms?
Matthias, Borowski +5 more
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The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to patient safety due to missing or suppressed alarms are being reported. The purpose of this paper is to present results from a workshop titled "Too many alarms?
Matthias, Borowski +5 more
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2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2009
The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and ...
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The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and ...
openaire +2 more sources
Critical Care Nursing Clinics of North America, 2002
This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical
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This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical
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The 26th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2005
Medical device security represents a growing problem within the healthcare industry. An increasing number of medical devices and systems contain critical health related information for which integrity, availability, and confidentiality must be maintained.
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Medical device security represents a growing problem within the healthcare industry. An increasing number of medical devices and systems contain critical health related information for which integrity, availability, and confidentiality must be maintained.
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Medical devices regulations and the Medical Devices Agency
British Journal of Nursing, 2002Pansy suffered from a chronic lung condition which required frequent courses of antibiotics. As her veins were poor and cannulation was difficult, a passport was inserted into a vein in her arm in which antibiotics and other solutions were administered.
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2004
The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing, large-scale production, certification, and distribution ...
Verkerke, G.J. +13 more
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The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing, large-scale production, certification, and distribution ...
Verkerke, G.J. +13 more
openaire +2 more sources