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Approved first in Japan in 1994 and qualifying for CE marking in 1998, Toraymyxin is indicated for use in the treatment of patients with sepsis or septic shock caused by gram-negative bacteria by selectively removing endotoxins from the circulating blood of patients [10].
Under the current system, a manufacturer selects a notified body to undertake certification of a new device for CE marking.
Clinical data used for CE marking may be either a review of the relevant scientific literature or the results of a clinical study.
In conclusion, the significant differences in protocol between the Khan et al. study and that specified by ISO 15197 as needed to determine accuracy clearly invalidate the study conclusions that the GlucoRx Nexus Voice system does not meet the minimum accuracy requirements specified for CE marking.
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These results will be the basis for declaring the properties of construction products as part of CE marking for marketing within Europe.
Test materials were provided at no cost by Alere Scarborough, Inc. Test protocols were developed by the authors together with personnel at Alere Scarborough, Inc. to comply with rigorous industry standards required for Conformite Europeene (CE) marking and test registration.
This is inadmissible and, for this reason, I request the European Commission to launch campaigns informing the European consumers so that they would not mistake the CE marking for a quality and safety mark.
Therefore, we all agree that the current CE marking system for products is not able to represent a guarantee of safety for the European consumers.
Currently the LFA has CE marking (a mandatory conformance marking for the European Economic Area) for use in the European Union and in countries that use CE approval and has been submitted to the United States Food and Drug Administration for approval (personal communication, Sean Bauman, IMMY).
Citizens are calling for initiatives and sanctions, and for customs controls to be stepped up, to prevent the European CE marking from being improperly exploited.
The GeneXpert CT/NG test was approved by the Therapeutic Goods Administration for diagnostic purposes in Australia in March 2013, and obtained Conformité Européenne (CE) marking and US Food and Drugs Administration FDAA) clearance in 2012.
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