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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.
The function point is a "unit of measurement" to express the amount of business functionality an information system (as a product) provides to a user. Function points are used to compute a functional size measurement (FSM) of software. The cost (in dollars or hours) of a single unit is calculated from past projects. [1]
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
The operations manual is the documentation by which an organisation provides guidance for members and employees to perform their functions correctly and reasonably efficiently. [1] It documents the approved standard procedures for performing operations safely to produce goods and provide services. [ 2 ]
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Lux meter for measuring illuminance, i.e. incident luminous flux per unit area; Luminance meter for measuring luminance, i.e. luminous flux per unit area and unit solid angle; Light meter, an instrument used to set photographic exposures. It can be either a lux meter (incident-light meter) or a luminance meter (reflected-light meter), and is ...
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The "Measurement Manual" defines the principles, rules and a process for measuring a standard functional size of a piece of software. Functional size is a measure of the amount of functionality provided by the software, completely independent of any technical or quality considerations. [ 1 ]