Study of the Evaluation Process of Class II Devices in the United States and the Relation with the Origin and Preparation of the Manufacturers
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Abstract—The global production of medical devices has increased due to growth in developing countries, hence the evaluation of pre marketing medical devices is needed to provide safety for patients and operators of such technology. In the US evaluation of medical devices is done before marketing depending on the type of device to be introduced. To market Class II devices the developer must present the application 510 (k) by which a study of "approval" of the new device is made to an existing one. However, many producers from different countries take more time to fulfill the requirements of the study indicating that they might not be fully prepared. This article aims to return the number of devices, the duration of study ti... Ver más
1909-9762
1909-9991
9
2015-09-24
info:eu-repo/semantics/openAccess
http://purl.org/coar/access_right/c_abf2
