UDI GS1 Datamatrix Generator
MDR / IVDR: Timeline – Changes – Impact
What is MDR/IVDRLegislationThe new European Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/ 746) replace the existing medical device directives.Since 25.05.2017, the EU regulations, the…
EUDAMED SAP Add-On demonstration
If you are a medical device manufacturer who have to meet the UDI requirements of the european union (EUDAMED) then is this video a must for you.Please enjoy our video. …
Breaking News: UDI FDA Compliance dates are postponed
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct MarkingFinal guidance from the US Food and Drug Administration pushes back enforcement…
UDI FDA SAP Add-On V2020/06 are released
The latest version of the UDI FDA SAP Add-On in version V2020 / 06 was published on June 11th, 2020.This includes various improvements and error corrections in order to optimally…
UDI data submission – the video tutorial
See the video tutorial how it worksUDI data transfer (2:26 min)
Europe IT Consulting GmbH is a member of the Swiss Medtech
We are very pleased that we can now call ourselves a member of the Swiss medical technology association Swiss Medtech. The association represents the values of the company which we…
Action required for medical device manufacturers in the UDI sector
GUDID / EUDAMEDWhat already is true for food today is also becoming reality for medical products. Traceability must be ensured, with the overriding goal of optimizing patient safety. Preparations at…
Happy Easter!
EUROPE IT Consulting GmbH wishes all customers a happy Easter and the best for 2020 despite current challenges.
UDI GS1 Barcode Generator for SAP
We have further developed our UDI GS1 Barcode Generator and increased the performance of barcode generation even more.As part of this development we have transferred the application to our own…
LIVE presentation of the UDI EUDAMED SAP Add-On
Dear customers,Dear interested parties,we will present the UDI EUDAMED SAP Add-On LIVE in our SAP system on 28 January 2020 from 10:00 to 11:30 a.m.We cordially invite you to this…
