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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.
Venereal Diseases Research Laboratory (old test for syphilis) VE: vaginal examination (manual examination) VEB: ventricular ectopic beat: VED: Vacuum Erection Device VEE: Venezuelan equine encephalitis: VF V-fib: ventricular fibrillation: VFSS: videofluoroscopic swallow study: VH: visual hallucinations vaginal hysterectomy VHL: Von Hippel ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
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.
This advisory committee has held 7 meetings since 2017 and has provided recommendations on complex issues, including patient engagement in clinical trial design and conduct, use of patient-generated health data in post-market surveillance, communications about medical devices, such as communications regarding cybersecurity vulnerabilities, AR ...
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls as described below are met. [3] The vast majority of new medical devices (99%) enter the marketplace via this process.