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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.
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.
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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 ...
In April 2018, Topcon established a medical software division, Topcon Healthcare Solutions, Inc., a developer of eyecare software and provider of related healthcare services. Topcon ophtalmic machines are widely used in many health centers in Western Europe, and are often interconnected to their surrounding IT systems through the RS232 protocol.
Orbotech Ltd. a subsidiary of KLA Corporation and a technology company used in the manufacturing of consumer and industrial products throughout the electronics and adjacent industries. The company providing electronics reading, writing, and connecting solutions used by manufacturers of printed circuit boards, flat panel displays, advanced ...
Automatic test equipment diagnostics is the part of an ATE test that determines the faulty components. ATE tests perform two basic functions. The first is to test whether or not the Device Under Test is working correctly. The second is when the DUT is not working correctly, to diagnose the reason.
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.