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The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
The Institute for Clinical and Economic Review provides independent evaluation of the clinical effectiveness and comparative value of health care interventions, while also overseeing the New England Comparative Effectiveness Public Advisory Council (CEPAC), an independent body of physicians and patient representatives that aids patients ...
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
ICH E1: Population exposure: the extent of population exposure to assess clinical safety [19] presents an accepted set of principles for the safety evaluation of drugs intended for the long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening diseases.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
The Journal of Evaluation in Clinical Practice is a quarterly peer-reviewed medical journal covering the evaluation of clinical practice in all medical and health disciplines. It was established in 1995 and is published by Wiley-Blackwell. The editor-in-chief is Mathew Mercuri ([University of Toronto]).
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]