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The Simple Function Point (SFP) method [1] is a lightweight Functional Measurement Method. The Simple Function Point method was designed by Roberto Meli in 2010 to be compliant with the ISO14143-1 standard and compatible with the International Function Points User Group (IFPUG) Function Point Analysis (FPA) method.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Certified reference materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. [1] A certified reference material is a particular form of measurement standard.
Rather than relying on a single template, multiple templates can be used. The idea is to represent an image as a deformed version of one of the templates. For example, there could be one template for a healthy population and one template for a diseased population. However, in many applications, it is not clear how many templates are needed.
In size theory, the size function (,): + = {(,): <} associated with the size pair (,:) is defined in the following way. For every (,) +, (,) (,) is equal to the number of connected components of the set {: ()} that contain at least one point at which the measuring function (a continuous function from a topological space to [1] [2]) takes a value smaller than or equal to . [3]
The term clinical engineering was first used in a 1969 paper by Landoll and Caceres. [2] Caceres, a cardiologist, is generally credited with coining the term.. The broader field of biomedical engineering also has a relatively recent history, with the first inter-society engineering meeting focused on engineering in medicine probably held in 1948.
HL7 was founded in 1987 to produce a standard for the exchange of data with hospital information systems.Donald W. Simborg, the CEO of Simborg Systems took the initiative to create the HL7 organization with the aim to allow for wider use of its own exchange protocol (known as the StatLAN protocol, originally defined at the University of California, San Francisco in the late 1970s).
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