MDR Eudamed Training Workshop: Preparation for EU MDR Eudamed

Aug
15
Date: 15th August 2019
Time: 09:00 - 17:30
Duration: 1 Day
Venue: Clayton Hotel, Galway
Address:
Event details

MDR Eudamed Training Workshop: Preparation for EU MDR Eudamed

 

8:30 Registration/Welcome


9:00 - 9:30 Determining any additional attendee needs & experience & Required registration for SRN & Security Code

9:30 – 10:30 Overview of MDR Eudamed:
● Strategic Timelines
● Overview of MDR Eudamed upload options
● Basics of Data Exchange and eDelivery

10:30 - 11:00 Coffee

11:00 - 12:00

● EC UDI Device services
● Pull & Push, Pagination
● Limits on file sizes

12:00 - 13:00

● eDelivery XML envelope
● MDR/IVDR/SPPP UDI XSDs and XML preparation

13:00 - 13:45 Lunch

13:45 - 14:45

● UDI & UDI-DI XML Requirements
● Packaging XML
● Market Info XML

14:45 – 15:00 Break

15:00 – 17:00 Generalities:
● Business Rules
● Data Dictionary
● Eudamed.eu options software/support

17:00 – 17:30 Closing Discussion and Q&A

17:30 Close

For all queries on the event, please call the event organiser:
Michelle Reinecke-Quain, Tel: +353 61 431802

Price
Per delegate: €1,500.00
(plus VAT)
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