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Medical equipment management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare ...
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [ 1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
IEC 60601. IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 ...
Endrov Image and data viewer and editor. It is available under the BSD license. [40] GIMIAS is a workflow-oriented environment focused on biomedical image computing and simulation. It is available under a BSD-style license. [41] Ginkgo CADx Cross-platform open source DICOM viewer and dicomizer.
An endoscope is an inspection instrument composed of image sensor, optical lens, light source and mechanical device, which is used to look deep into the body by way of openings such as the mouth or anus. A typical endoscope applies several modern technologies including optics, ergonomics, precision mechanics, electronics, and software ...
A biomedical engineering/equipment technician/technologist ( 'BMET ') or biomedical engineering/equipment specialist ( BES or BMES) is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or ...
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. It has been adopted as national standards and ...
Standalone software used for diagnostic or therapeutic purposes. Software embedded in a medical device (often referred to as "medical device software"). Software that drives a medical device or determines how it is used. Software that acts as an accessory to a medical device. Software that provides quality control management of a medical device.