Examples of using Performance evaluation in English and their translations into Croatian
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Colloquial
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Ecclesiastic
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Computer
Putting into service' means the stage at which a device, other than a device for performance evaluation, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;
Text proposed by the Commission Amendment(35)‘ performance evaluation' means the assessment
legal person responsible for the manufacture of the device intended for performance evaluation, this obligation may be fulfilled by that person on behalf of the sponsor.
other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. .
(32) The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up.
Manufacturers of devices classified as class A, other than devices for performance evaluation, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 15,
other than devices for performance evaluation, the manufacturer shall draw up a report on the safety
The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII
data generated in performance studies should be based on a performance evaluation plan.
other than a device for performance evaluation, is placed on the market the manufacturer
such as performance evaluation or vigilance reporting,
other than a device for performance evaluation, for distribution, consumption
a serious adverse event that has a causal relationship with the device for performance evaluation, the comparator or the study procedure
scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study,
Analytical and performance evaluation cookies enable us to recognize
For devices for performance evaluation intended to be used in the context of interventional clinical performance studies
safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several Member Stats,
the requirements for performance studies and performance evaluation and/or post-market follow-up,
results of non-clinical testing methods alone, including performance evaluation, bench testing
which increasingly will go hand in hand with a performance evaluation.