Complying with UDI Part 4 – EUDAMED and its modules according to MDR Art. 33 and 34
Complying with UDI | Part 4 – EUDAMED and its modules according to MDR Art. 33 and 34
This webinar addresses the topics of identification/labelling requirements and implementation (webinar in English).
UDI data is recorded in the EUDAMED. This webinar will explain about the aim of the database, as well as its structure and functional characteristics. We will also discuss the differences between the EUDAMED and the US UDI database, and explain the importance of the database for your company.
This webinar is one of a four-part series:
- Complying with UDI | Part 1 – fundamentals
- Complying with UDI | Part 2 – Basic UDI-DI
- Complying with UDI | Part 3 – Labeling in accordance with MDR Art. 2, 12
- Complying with UDI | Part 4 – EUDAMED and its modules according to MDR Art. 33 and 34
The webinar also talks about the use of GS1 standards in association with UDI. However, these standards will not be addressed in detail. Further information about GS1 standards and their use can be found in the webinar UDI mit GS1 Standards umsetzen or in the seminar Get ready for UDI! UDI–Anforderungen mit GS1 Standards erfüllen.
You will have gained comprehensive knowledge about UDI by the end of the course, allowing you to begin implementing it immediately.
Managers and specialists in the fields of
- quality assurance
- IT or export
who are working for manufacturers of medical devices and technology and who are involved in the implementation of UDI requirements.
About Jay Crowley
Jay Crowley is currently Vice President, UDI Solutions and Services, at USDM Life Sciences. Prior to joining the firm in January 2014, Crowley was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.