HSA
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
FDA
The new article highlights the key points related to the specific aspects of selecting proper predicates to demonstrate compliance with the applicable regulatory requirements for the medical device in question is subject to.
BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
FDA
The article provides an overview of the existing framework for electronic thermometers.
HSA
The new article highlights the aspects related to the general principles of clinical evaluation.
