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Common setups include the interfacing of CGMs, Insulin Pumps, and Raspberry Pi devices. It is released under the MIT license, but compatible medical devices are proprietary. [59] Ushahidi allows people to submit crisis information through text messaging using a mobile phone, email or web form. Displays information in map view.
Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems ...
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.
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.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
OpenEMR is free and open-source software subject to the terms of the GNU General Public License (GPL). It is actively internationalized and localized in multiple languages, and free support is available in online forums around the world. At the time of this writing, commercial support is offered by over 30 vendors in over 10 countries. [5]
Instrument Uses; Bandage: material used to support a medical dressing or injured body part : Bedpan: for patients who are unconscious or too weak to sit up or walk to the toilet to defecate
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 ...