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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 ...
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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 Measuring Instruments Directive 2014/32/EU, formerly 2004/22/EC, is a directive by the European Union, which seeks to harmonise many aspects of legal metrology across all member states of the EU. [1] Its most prominent tenet is that all kinds of meters which receive a MID approval may be used in all countries across the EU.
There is also the Rayleigh Refractometer used (typically) for measuring the refractive indices of gases. In laboratory medicine, a refractometer is used to measure the total plasma protein in a blood sample and urine specific gravity in a urine sample. In drug diagnostics, a refractometer is used to measure the specific gravity of human urine.