keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day One – 10 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
keyboard_arrow_leftSearch & Filter
search
Streams
Clear
Day One – 10 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
search
Streams
Clear
Showing 1 of 1 Streams
In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
09:00 - 09:10
Chairperson’s Opening Remarks: In Vitro Diagnostic Workshop
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED
09:10 - 10:40
The Pre-Application Phase
- Structure of a Technical Documentation file
- Notified Body code assignment
- Classification
- Creation of sampling groups
Showing 1 of 1 Streams
In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
11:10 - 12:40
Directive to Regulation Data
- Completion of a gap assessment
- Tips to score with your NB
- State of the art concept
Showing 1 of 1 Streams
In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Workshop
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Tom Patten - Certification and Inspection Officer (IVD), National Standards Authority of Ireland (NSAI)
- Liz Gommans - Technical Professional, DEKRA
- Catherine Holzmann - Certification Division Manager In Vitro Diagnostics Medical Devices, GMED
14:15 - 15:45
Performance Evaluation and Clinical Evidence
- How to demonstrate Performance Evaluation and Clinical Evidence
Showing 1 of 1 Streams
In Vitro Diagnostic Workshop: Compiling and Completing Technical Documentation
16:15 - 17:45
Clinical Evidence (continued) and Post Market Surveillance
- IVDR requirements & NB expectations
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Streams
Clear