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Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
The global IEC 62304 standard on the software life cycle processes of medical device software states it is a "software system that has been developed for the purpose of being incorporated into the medical device being developed or that is intended for use as a medical device in its own right."
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.
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.
Nightscout is a collection of software tools, including mobile clients, to enable DIY cloud-based continuous glucose monitoring "…for informational and educational purposes." [ 31 ] Individual components are available under various open-source licenses, including the GNU GPL , [ 32 ] GNU AGPL , [ 33 ] MIT License , [ 34 ] and BSD licenses .
CompuGroup Medical SE & Co. KGaA (also known as CGM) is a publicly listed software company based in Koblenz that develops and offers software for the healthcare sector. It produces cloud-based and digital application software to support medical and organizational activities in doctors' practices, pharmacies, medical laboratories and hospitals ...
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The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...