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PROMIS has worked to unify the field of patient-reported outcome (PRO) measurement through the promotion of a common, systematic measurement system broadly applicable across clinical research. PROMIS measures are intended to assess the most common or salient dimensions of patient–relevant outcomes for the widest possible range of chronic ...
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.
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.
to measure concentration of glucose in blood: Haemodialysis machine: to remove toxic materials from the blood that are generally removed by the kidneys; used in case of kidney failure [3] Hypodermic needle / Syringe: for injections and aspiration of blood or fluid from the body Infection control equipment
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
Multimodal monitors that simultaneously measure and display the relevant vital parameters are commonly integrated into the bedside monitors in critical care units, and the anesthetic machines in operating rooms. These allow for continuous monitoring of a patient, with medical staff being continuously informed of the changes in general condition ...