FDA
The new article describes in detail the approach to be applied with respect to re-training of medical devices utilising machine learning technology, and also the aspects associated with the evaluation of their performance after the modifications are implemented. Table...
Europe
The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom. Table of Contents The...
FDA
The new article highlights the aspects related to the approach to be applied when assessing the changes and the impact they have on the actual performance of the test system in question, as well as the safety of patients. Table of Contents The Food and Drug...
IMDRF
The new article describes in detail the approach to be applied with respect to the third and fourth stages of the total product life cycle, as well as to the risk assessment in the context of transition between the stages. Table Of Contents: The International Medical...
FDA
The new article highlights the aspects related to data management and describes the way they should be addressed in a modification protocol. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
