Content
The EU MDR introduces the UDI as a central identifier for medical devices for documentation, information, tracing, logistics and reporting. In the seminar, UDI is discussed as a marking on the product and the product packaging. The second focus is testing the marking for quality assurance according to FDA and EU-MDR.
Topic overview
- UDI at a glance: documentation, logistics, reporting, information
- UDI concept: marking, EUDAMED and dates
- Which packaging level should be marked?
- Selection of code symbology: 1D and matrix codes
- Code design according to the specifications of the coding organizations: GS1, HIBCC, ICCBBA, IFA
- Selection of fields: batch, serial number, expiry date, manufacturing date
- Plain text: interpretation line, symbols and date format
- UDI testing: Marking in quality management
- Direct marking on the medical device: marking technology and strategy
- Preparation of UDI database GUDID and EUDAMED
target group
Production, product design, regulatory affairs, QM, marketing, processing.
Prior knowledge
Affinity for medical devices and labels.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
