Primjeri korištenja Performance evaluation na Engleski i njihovi prijevodi na Hrvatskom
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For monitoring and performance evaluation;
Performance evaluation and clinical evidence 1.
The description of the device for performance evaluation;
Regularly carry out performance evaluation so that the employees know what is expected of them.
Scientific validity determination and performance evaluation.
Devices for performance evaluation shall be subject to the requirements set out in Articles 48 to 58.
No progress has been made regarding reports on performance evaluation and quality control procedures.
Erdem, R. T.: Performance evaluation of reinforced concrete buildings with softer ground floors, GRAĐEVINAR, 68(2016) 1, pp.
The notified body shall clearly document the outcome of its assessment in the performance evaluation assessment report.
The risk management and performance evaluation processes should be inter-dependent and should be regularly updated.
(14)'placing on the market' means the first making available of a device,other than a device for performance evaluation, on the Union market;
For devices, other than devices for performance evaluation, a system for Unique Device Identification shall be put in place in the Union.
The notified body shall provide the manufacturer with a report on the technical documentation assessment,including a performance evaluation assessment report.
In the case of devices for performance evaluation classified as class C or D, as soon as the Member State concerned has notified the sponsor of its approval;
To provide views in accordance with Article 48(4) of Regulation(EU)2017/746 on the performance evaluation of certain in vitro diagnostic medical devices. 11.
For devices, other than devices for performance evaluation, economic operators shall be able to identify the following, for the period referred to in Article 84.
Take effective measures to fight corruption, enhancing transparency and accountability, andintroducing external performance evaluation and quality control procedures.
Section 9: Performance evaluation- This section includes the requirements needed to make sure that you can monitor whether your EMS is functioning well.
In the case of devices classified as class C and D,other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. .
The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph.
When clinical performance studies are conducted,the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.
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 and the post-market surveillance plan referred to in Article 79.
If different from the above, name, address andcontact details of the manufacturer of the device intended for performance evaluation and, if applicable, of his authorised representative.
Text proposed by the Commission Amendment(35)‘ performance evaluation' means the assessment and analysis of data to establish or verify the analytical and, where applicable, the clinical performance of a device;
If the sponsor is not the natural orlegal 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.
The EESC agrees with the current trend towards greater emphasis on performance and results, as demonstrated by the work of the European Commission(Budget Focused on Results Initiative4) and the European Court of Auditors the structure of its annual report for 20145 and the special chapter on performance; the passages on shared management include the initial results of the performance evaluation programme carried out as a pilot exercise.
Within one week after placing a device,other than a device for performance evaluation, on the market, importers shall submit to the electronic system the information referred to in paragraph 1.
The clinical evidence shall support the intended purpose of the device as stated by the manufacturer andbe based on a continuous process of performance evaluation, following a performance evaluation plan.
Any adverse event that has a causal relationship with the device for performance evaluation, the comparator or the study procedure or where such causal relationship is reasonably possible; Amendment 179.
The allocation of appropriately qualified and authorised personnel for the examination of individual aspects, such as use of the device,biocompatibility, performance evaluation, risk management and sterilisation, and.