Regulatory management is important for ensuring compliance in a variety of industries but is especially crucial for medical device manufacturers. However, regulatory information management systems for medical devices often remain behind the times and are held back by...
The new article highlights the aspects related to the safety measures to be introduced by study sponsors, as well as the way adverse events associated with a medical device in question should be reported to the authority. Table of Contents The Swiss regulating...
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...
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...
The new article highlights the aspects related to modifications to performance studies. In particular, the authority describes the approach to be applied when determining the regulatory status of modifications, as well as subsequent procedures to be followed by study...
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...