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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.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
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
An early warning system (EWS), sometimes called a between-the-flags or track-and-trigger chart, is a clinical tool used in healthcare to anticipate patient deterioration by measuring the cumulative variation in observations, most often being patient vital signs and level of consciousness. [1]
English: This psychrometric chart represents the acceptable combination of air temperature and humidity values, according to the PMV/PPD method in the ASHRAE 55-2010 Standard. The comfort zone in blue represents the 90% of acceptability, which means the conditions between -0.5 and +0.5 PMV, or PPD < 10%.
It is not always necessary to validate an ePRO measure against a pre-existing paper version. In some cases, an instrument may be developed and validated from the beginning in electronic form. More commonly, perhaps, new instruments will be developed in parallel for paper and electronic use, as is the case with the PROMIS (Patient-Reported ...
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...