Technical Files and Design Dossiers for IVD‘s

A required part of conformity assessment and CE-marking is the need for a Technical File (called a Design Dossier for high risk devices), which includes the collation of supporting information about your IVD device. Learn how to assemble this and other types of required information, so you can CE Mark your device in Europe. You’ll also learn potential changes that may impact your Technical Documentation under the proposed future IVDR.