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This term was chosen over the more commonly used term of "human error" because not all errors associated with the use of medical device are the result of oversight or carelessness of the part of the user of the medical device. Much more commonly, use errors are the direct result of poor user interface design."
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.
The IEC 62366 standard aims to reduce errors caused by inadequate medical device usability. Such errors have become an increasing cause for concern. 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.
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
In Division 2, the Knox-Keene Health Care Service Plan Act of 1975 in Division 2. Chapter 2.2., 1340 - 1399.864, [13] which is enforced by the California Department of Managed Health Care and regulates most health insurance in California, although some plans are regulated by the California Department of Insurance (CDI) with sometimes similar "companion" statutes in the California Insurance ...
The surgeon’s license of Hanford physician David Wayne Nelson is to be revoked by the California Medical Board after the board determined Nelson was guilty of gross negligence by performing a ...
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The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.