Feb 21, 2024
EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
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Dec 19, 2023
HSA
The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.
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Nov 29, 2023
HSA
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
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Nov 22, 2023
HSA
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
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Nov 22, 2023
HSA
The new article highlights the aspects related to the general principles of clinical evaluation.
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