![]() ![]() Ī portable heart rate variability device is an example of a medical device that contains medical device software. Food and Drug Administration (FDA) has also offered guidance and driven regulation on medical software, particularly embedded in and used as medical devices. The development of the ISO 9000-3 standard as well as the European Medical Devices Directive in 1993 helped bring some harmonization of existing laws with medical devices and their associated software, and the addition of IEC 62304 in 2006 further cemented how medical device software should be developed and tested. Medical software became more prominent in medical devices in fields such as nuclear medicine, cardiology, and medical robotics by the early 1990s, prompting additional scrutiny of the "safety-critical" nature of medical software in the research and legislative communities, in part fueled by the Therac-25 radiation therapy device scandal. As computing became more widespread and useful in the late 1970s and into the 1980s, the concept of "medical software" as a data and operations management tool in the medical industry - including in the physician's office - became more prevalent. Medical software has been in use since at least since the 1960s, a time when the first computerized information-handling system in the hospital sphere was being considered by Lockheed.
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