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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
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.
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.
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.
The Joint Committee for Guides in Metrology (JCGM) is a committee which created and maintains two metrology guides: Guide to the expression of uncertainty in measurement (GUM) [55] and International vocabulary of metrology – basic and general concepts and associated terms (VIM). [34] The JCGM is a collaboration of eight partner organisations ...
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.