BSI offers a range of training courses, suitable for those new to regulatory affairs through to those wanting to develop their knowledge and understanding on particular topics. See our IVD-specific courses below, or visit our training pages for more information.
Technical files and design dossiers for In Vitro Diagnostics
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.
Performance evaluation and clinical evidence for In Vitro Diagnostics
When placing an IVD device on the European market, you must demonstrate that it complies with necessary regulatory requirements through appropriate conformity assessment procedures. Learn how to plan for appropriate performance studies for your IVD device and gather required information and data needed for a body of clinical evidence under the proposed future IVDR.