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In that case, manufacturers' evaluation of drug administration costs should be done in the same manner as it will be conducted by healthcare payers.
The relevant data items for an MDR are: (i) device type and model, (ii) report source (e.g. hospital or manufacturer), (iii) event date and location, (iv) device age, (v) patient outcome, (vi) a narrative of the event, and (vii) the manufacturers evaluation of returned devices if available.
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These adopted direct transformation evaluation scripts for HR-pQCT are now included in current upgrades of manufacturer evaluation software.
They performed semi-automated contouring of the periosteal bone surface and segmented bone from surrounding soft tissue using standard manufacturer evaluation script protocols [ 48].
Using the manufacturer evaluation software (V 6.0), the operator analyzed five sub-regions of interest [1 - UUD radius (110 slices); 2 - MH2 & MH3 (110 slices); 2 - MS2 and MS3 (110 slices)].
The operator then ran a series of evaluation scripts using the manufacturer evaluation software for assessment of the full, cortical and trabecular bone regions using direct transformation image analyses scripts adapted from standard microCT evaluation scripts recently developed for cortical bone and described in more detail by Nishiyama KK et al. [ 40], and Liu XS et al., [ 41].
Combined with the characteristics of automobile manufacturers, the evaluation index system of reverse logistics partner was constructed including cost, environment performance, service capacity and basic quality of the enterprise, then a new method of aggregating weight of the above indexes is supported, and TOPSIS method is used to evaluate the several partners.
Analysis was performed using the manufacturer's evaluation software (Scanco µCT100, Scanco Medical, Bassersdorf, Switzerland) using a fixed global threshold of 28% (280 on a grayscale of 0 1000) to segment bone from nonbone.
The G-BA decision is based on the manufacturers' dossier, IQWiG evaluation, as well as the results of a public hearing.
All manufacturers in this evaluation have current ISO 13485:2003 certification, a standard designed to give assurance of consistency of quality of final product; however, it cannot be guaranteed that the results here will predict results from different RDT lots.
The EIA and TPHA kits were kindly donated by the manufacturer for this evaluation.
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