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...
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 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 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...
The new article highlights the aspects related to the review of the application by the authority and regulatory decisions the authority may take based on the results of such a review. Table of Contents The Swiss regulatory agency in the sphere of healthcare products,...