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Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems ...
Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
A failure reporting, analysis, and corrective action system (FRACAS) is a system, sometimes carried out using software, that provides a process for reporting, classifying, analyzing failures, and planning corrective actions in response to those failures.
The Therapeutic Goods (Medical Devices) 2007 Regulations require a healthcare facility that reprocesses single-use devices to be licensed as a manufacturer. A healthcare facility that reprocesses single use devices would be considered to be a manufacturer under the Act and thus would be required to conform to the regulation and be subject to ...
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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Remedial Action is often enacted through ‘Remedial Action Plans’ (RAPs) of three or more stages. For example, one North American river protection scheme drew up a plan that identified environmental problems and sources of pollution, evaluated and carried out actions to restore the area, and confirmed that these actions had been effective [3]
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.