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),...
FDA
The new article addresses the aspects related to the connection between different sections of a predetermined change control plan, as well as to the impact assessment medical device manufacturers should perform in order to ensure the modifications will not affect the...
IMDRF
The new article highlights the aspects related to the first two stages of the total product life cycle, namely the initial development, when the product is being created, and support – the period that starts from the moment the product becomes available on the...
