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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.
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed ...
The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc. (a medical Instrumentation marketing firm in Needham, Massachusetts).
Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined regulations, but also to provide an official certification mark or a declaration of conformity. [4] [5]