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The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation.
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
Medical technology assessment (MTA) is the objective evaluation of a medical technology regarding its safety and performance, its (future) impact on clinical and non-clinical patient outcomes as well as its interactive effects on economical, organizational, social, juridical and ethical aspects of healthcare. Medical technologies are assessed ...
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 ...
Device History Record (DHR) Design History File (DHF) 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.
The program evaluation and review technique (PERT) is a statistical tool used in project management, which was designed to analyze and represent the tasks involved in completing a given project. PERT was originally developed by Charles E. Clark for the United States Navy in 1958; it is commonly used in conjunction with the Critical Path Method ...
Age: If the device is put into a child, the child's growth means that the catheter becomes relatively shorter and will move towards the head. It may become necessary to remove or replace it. Vascular occlusion : formation of a blood clot between the catheter and the vascular wall leading to partial or complete occlusion of the vein.
The CIPP evaluation model is a program evaluation model which was developed by Daniel Stufflebeam and colleagues in the 1960s. CIPP is an acronym for context, input, process and product. CIPP is a decision-focused approach to evaluation and emphasizes the systematic provision of information for program management and operation. [1]