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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.
Nondestructive testing. X-ray vault used in Radiography. Nondestructive testing ( NDT) is any of a wide group of analysis techniques used in science and technology industry to evaluate the properties of a material, component or system without causing damage. [ 1] The terms nondestructive examination ( NDE ), nondestructive inspection ( NDI ...
Quality assurance. Quality assurance ( QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product (s) delivered to customer (s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer.
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.
A quality management system ( QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015 ). [ 1] It is expressed as the organizational goals and aspirations, policies, processes, documented ...
Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity [1] [2] [3] 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 ...
Conformance testing. Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.