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The SOFTWARE SYSTEM is software safety class A if: the SOFTWARE SYSTEM cannot contribute to a HAZARDOUS SITUATION; or; the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which does not result in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM. The SOFTWARE SYSTEM is software safety class B if:
Unlike the regular version, this version is certified for medical imaging. OsiriX MD is a FDA cleared 510k class II medical device, according to US Food And Drug Regulation CFR21 part 820. OsiriX MD complies with European Directive 93/42/EEC concerning medical devices. Under this directive, it is regarded as a class IIa.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
However, with ongoing technological advances many Class III devices encompass concepts not previously marketed, These devices may not fit the scope of established device categories and do not yet have developed FDA guidelines. [16] Examples of Class III devices that require a premarket notification include implantable pacemaker, pulse ...
Following the passing of the Act, there were calls for the FDA to publish a timeline for the implementation of the UDI; [6] this was subsequently done. [7] GUDID Submission The Final Rule on Unique Device Identifiers also mandates medical device manufacturers to make a submission to the FDA's Global Unique Device Identification Database.
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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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...