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.
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.
HSA
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
HSA
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
HSA
The new article highlights the aspects related to the general principles of clinical evaluation.
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