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Medical Software
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity * standalone software used for diagnostic or therapeutic purposes; * software embedded in a medical device (often referred to as "medical device software"); * software that drives a medical device or determines how it is used; * software that acts as an accessory to a medical device; * software used in the design, production, and testing of a medical device; or * software that provides quality control management of a medical device. History 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. 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 — ...
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Software
Software is a set of computer programs and associated documentation and data. This is in contrast to hardware, from which the system is built and which actually performs the work. At the lowest programming level, executable code consists of machine language instructions supported by an individual processor—typically a central processing unit (CPU) or a graphics processing unit (GPU). Machine language consists of groups of binary values signifying processor instructions that change the state of the computer from its preceding state. For example, an instruction may change the value stored in a particular storage location in the computer—an effect that is not directly observable to the user. An instruction may also invoke one of many input or output operations, for example displaying some text on a computer screen; causing state changes which should be visible to the user. The processor executes the instructions in the order they are provided, unless it is instructed ...
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Lesion
A lesion is any damage or abnormal change in the tissue of an organism, usually caused by disease or trauma. ''Lesion'' is derived from the Latin "injury". Lesions may occur in plants as well as animals. Types There is no designated classification or naming convention for lesions. Since lesions can occur anywhere in the body and the definition of a lesion is so broad, the varieties of lesions are virtually endless. Generally, lesions may be classified by their patterns, their sizes, their locations, or their causes. They can also be named after the person who discovered them. For example, Ghon lesions, which are found in the lungs of those with tuberculosis, are named after the lesion's discoverer, Anton Ghon. The characteristic skin lesions of a varicella zoster virus infection are called '' chickenpox''. Lesions of the teeth are usually called dental caries. Location Lesions are often classified by their tissue types or locations. For example, a "skin lesion" or a " bra ...
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Health Information Technology
Health information technology (HIT) is health technology, particularly information technology, applied to health and health care. It supports health information management across computerized systems and the health information exchange, secure exchange of health information between consumers, health professional, providers, payment, payers, and health care quality, quality monitors. Based on a 2008 report on a small series of studies conducted at four sites that provide ambulatory care – three U.S. medical centers and one in the Netherlands, the use of electronic health records (EHRs) was viewed as the most promising tool for improving the overall quality, safety and efficiency of the health delivery system. Risk-based regulatory framework for health IT September 4, 2013 the Health IT Policy Committee (HITPC) accepted and approved recommendations from the Food and Drug Administration Safety and Innovation Act (FDASIA) working group for a risk-based regulatory framework for heal ...
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Health Informatics
Health informatics is the field of science and engineering that aims at developing methods and technologies for the acquisition, processing, and study of patient data, which can come from different sources and modalities, such as electronic health records, diagnostic test results, medical scans. The health domain provides an extremely wide variety of problems that can be tackled using computational techniques. Health informatics is a spectrum of multidisciplinary fields that includes study of the design, development and application of computational innovations to improve health care. The disciplines involved combines medicine fields with computing fields, in particular computer engineering, software engineering, information engineering, bioinformatics, bio-inspired computing, theoretical computer science, information systems, data science, information technology, autonomic computing, and behavior informatics. In academic institutions, medical informatics research focus on a ...
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Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical de ...
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ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ...
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Quality Management System
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. ...
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United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washington, D.C. Senators and representatives are chosen through direct election, though vacancies in the Senate may be filled by a governor's appointment. Congress has 535 voting members: 100 senators and 435 representatives. The U.S. vice president has a vote in the Senate only when senators are evenly divided. The House of Representatives has six non-voting members. The sitting of a Congress is for a two-year term, at present, beginning every other January. Elections are held every even-numbered year on Election Day. The members of the House of Representatives are elected for the two-year term of a Congress. The Reapportionment Act of 1929 establishes that there be 435 representatives and the Uniform Congressional Redistricting Act requires ...
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Heart Rate Monitor
A heart rate monitor (HRM) is a personal monitoring device that allows one to measure/display heart rate in real time or record the heart rate for later study. It is largely used to gather heart rate data while performing various types of physical exercise. Measuring electrical heart information is referred to as electrocardiography (ECG or EKG). Medical heart rate monitoring used in hospitals is usually wired and usually multiple sensors are used. Portable medical units are referred to as a Holter monitor. Consumer heart rate monitors are designed for everyday use and do not use wires to connect. History Early models consisted of a monitoring box with a set of electrode leads which attached to the chest. The first wireless EKG heart rate monitor was invented in 1977 by Polar Electro as a training aid for the Finnish National Cross Country Ski team. As "intensity training" became a popular concept in athletic circles in the mid-80s, retail sales of wireless personal heart mo ...
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Body Mass Index
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. The BMI may be determined using a table or chart which displays BMI as a function of mass and height using contour lines or colours for different BMI categories, and which may use other units of measurement (converted to metric units for the calculation). The BMI is a convenient rule of thumb used to broadly categorize a person as ''underweight'', ''normal weight'', ''overweight'', or ''obese'' based on tissue mass (muscle, fat, and bone) and height. Major adult BMI classifications are underweight (under 18.5 kg/m2), normal weight (18.5 to 24.9), overweight (25 to 29.9), and obese (30 or more). When used to predict an individual's health, rather than as a statistical measurement for groups, the BMI has limitations ...
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Spirometer
A spirometer is an apparatus for measuring the volume of air inspired and expired by the lungs. A spirometer measures ventilation, the movement of air into and out of the lungs. The spirogram will identify two different types of abnormal ventilation patterns, obstructive and restrictive. There are various types of spirometers that use a number of different methods for measurement (pressure transducers, ultrasonic, water gauge). Pulmonary function tests A spirometer is the main piece of equipment used for basic Pulmonary Function Tests (PFTs). Lung diseases such as asthma, bronchitis, and emphysema may be ruled out from the tests. In addition, a spirometer often is used for finding the cause of shortness of breath, assessing the effect of contaminants on lung function, the effect of medication, and evaluating progress for disease treatment. Reasons for testing * Diagnose certain types of lung disease (such as COVID-19, bronchitis, and emphysema) * Find the cause of shortness of b ...
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Stethoscope
The stethoscope is a medical device for auscultation, or listening to internal sounds of an animal or human body. It typically has a small disc-shaped resonator that is placed against the skin, and one or two tubes connected to two earpieces. A stethoscope can be used to listen to the sounds made by the heart, lungs or intestines, as well as blood flow in arteries and veins. In combination with a manual sphygmomanometer, it is commonly used when measuring blood pressure. Less commonly, "mechanic's stethoscopes", equipped with rod shaped chestpieces, are used to listen to internal sounds made by machines (for example, sounds and vibrations emitted by worn ball bearings), such as diagnosing a malfunctioning automobile engine by listening to the sounds of its internal parts. Stethoscopes can also be used to check scientific vacuum chambers for leaks and for various other small-scale acoustic monitoring tasks. A stethoscope that intensifies auscultatory sounds is called a phonen ...
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