FDA
The new article provides a brief overview of the new guidance document dedicated to the Q-Submission Program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
FDA
The new article highlights the aspects related to validation and verification activities to be conducted by medical device manufacturers to ensure the safety and proper performance of a new combination of an instrument and assay. Table of Contents The Food and Drug...
FDA
The new article highlights the aspects related to the risk assessment to be duly performed by a medical device manufacturer in order to identify new risks arising in connection to modifications suggested. Table of Contents The Food and Drug Administration (FDA or the...
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...
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...
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...
