Our Excel templates are now available for purchaseOur proven Excel templates are available for purchase in an optimised and user-friendly design. The templates for preparing, collecting and managing your UDI…
The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your…
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…
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. …
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…
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…
See the video tutorial how it worksUDI data transfer (2:26 min)
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…
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…
EUROPE IT Consulting GmbH wishes all customers a happy Easter and the best for 2020 despite current challenges.