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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.
Software that is intended to be used to view images, or other real time data, as an adjunct to the monitoring device itself, for the purpose of aiding in treatment or diagnosis of a patient, would be Class I medical devices. Medical device software that is an adjunct to another medical device and is involved in data manipulation, data analysis ...
Health information management's standards history is dated back to the introduction of the American Health Information Management Association, founded in 1928 "when the American College of Surgeons established the Association of Record Librarians of North America (ARLNA) to 'elevate the standards of clinical records in hospitals and other medical institutions.'" [3]
The development of the ISO 9000-3 standard [9] as well as the European Medical Devices Directive in 1993 [1] helped bring some harmonization of existing laws with medical devices and their associated software, and the addition of IEC 62304 in 2006 further cemented how medical device software should be developed and tested. [11]
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
That functionality can roughly be divided into five laboratory processing phases, with numerous software functions falling under each: [2] (1) the reception and log in of a sample and its associated customer data, (2) the assignment, scheduling, and tracking of the sample and the associated analytical workload, (3) the processing and quality ...
Software of unknown pedigree (SOUP) is software that was developed with a unknown process or methodology, or which has unknown or no safety-related properties. [1] In the medical device development standard IEC 62304, SOUP expands to software of unknown provenance, and in some contexts uncertain is used instead of unknown, but any combination of unknown/uncertain and provenance/pedigree refer ...
A software requirements specification (SRS) is a description of a software system to be developed.It is modeled after the business requirements specification.The software requirements specification lays out functional and non-functional requirements, and it may include a set of use cases that describe user interactions that the software must provide to the user for perfect interaction.
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