target group
Production, product design, regulatory affairs, QM, marketing, processing.
content
The EU-MDR introduces the UDI as the central ident for medical devices for documentation, information, traceability, logistics and reporting. In the seminar, UDI will be treated as a marking on the product and the product packaging. The second focus is the testing of 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 level of packaging indicate?
- Choice 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, date of manufacture
- Plain text: interpretation line, symbols and date format
- UDI check: Marking in quality management
- Direct marking on the medical device: marking technology and strategy
- Preparation of the UDI database GUDID and EUDAMED for the second part of the seminar
previous knowledge
Affinity for medical devices and labels.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
