IVDR Technical Documentation Training for Manufacturers
01/02/24
The aim of this training is to review the IVDR requirements related to Technical Documentation and share notified bodies insights; it is also planned to review the Team NB Technical Documentation Best Practice document for IVDR (published on March 1st 2023). The topics are presented by IVD experts of IVDR designated notified bodies.
Date & time: Thursday, February 1st 9:00-17:00 CET
Location: Remotely
Language: English
Registration fee: 900 Euros / organisation for up to 2 persons max.
Program:
- 9.00 to 9.30 Welcome
- 9.30 to 10.45 The (pre) application phase : Structure of a TD file, NB code assignment, classification, creation of sampling groups. Q&A moderated IVD expert
- 11.00 to 12.15 Directive to Regulation data : Completion of a gap assessment, tips & tricks, state of the art concept. Q&A moderated IVD expert
- 13.30 to 14.45 Performance Evaluation : How to demonstrate Performance Evaluation Q&A moderated IVD expert
- 15.00 to 16.15 Clinical Evidence and Post Market Surveillance : IVDR requirements & NB insights Q&A moderated IVD expert
- 16.15-17.00 Closing session: Summary of main elements, last questions & feedback and suggestions
Visit the event leaflet for more information or register here until January 4th.
