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...
Europe
The new article addresses the aspects related to surveillance activities to be carried out by the authority, as well as the applicable reporting requirements the parties responsible for performance investigations should follow. Table of Contents The Swiss regulating...
FDA
The present article provides an overview of the applicable regulatory policy introduced by the authority. 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 guidance...
Europe
The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices. Table of Contents The Medicines & Healthcare Products Regulatory Agency (MHRA),...
