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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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry ...
An insulin pump delivers insulin subcutaneously. The insulin pump body itself can also contain the algorithm used in an AID system, or it can connect via Bluetooth with a separate mobile device (such as a phone) to send data and receive commands to adjust insulin delivery. Algorithm. The algorithm for each AID system differs.
Unique Device Identification. The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section ...
A nasal spray bottle being demonstrated. Drug delivery refers to approaches, formulations, manufacturing techniques, storage systems, and technologies involved in transporting a pharmaceutical compound to its target site to achieve a desired therapeutic effect. [1] [2] Principles related to drug preparation, route of administration, site ...
Implant (medicine) Orthopedic implants to repair fractures to the radius and ulna. Note the visible break in the ulna. (right forearm) A coronary stent — in this case a drug-eluting stent — is another common item implanted in humans. An implant is a medical device manufactured to replace a missing biological structure, support a damaged ...
Use of real time monitoring of the heart in an intensive care unit in a German hospital (2015), the monitoring screen above the patient displaying an electrocardiogram and various values of parameters of the heart like heart rate and blood pressure. Electrocardiography is the process of producing an electrocardiogram ( ECG or EKG [a] ), a ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 ...