Europe
The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device Table of Contents The Swiss regulating authority...
Europe
The new article highlights the aspects related to serious adverse events, how they should be documented and reported, and the annual reporting requirements and procedures. Table of Contents The Swiss regulating authority in healthcare products (Swissmedic) has...
Europe
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...
Europe
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...
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...
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...
