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Handlungsbedarf für Medizinproduktehersteller im Bereich UDI GUDID / EUDAMED Was für Lebensmittel heute bereits gilt, wird auch für Medizinprodukte Realität. Die Rückverfolgbarkeit muss sichergestellt werden, mit dem übergeordneten Ziel, die…
Global UDI solution for MedTech companies
https://www.youtube.com/watch?v=5-3xiXmfjhg&feature=youtu.beLearn in this short video how our global UDI software solution helps you ensure a smooth and successful UDI implementation.
Single registration number (SRN) search is available
The first MedTech manufacturers have already got their SRN. If you want to find out which companies they are, please have a look on the following link: https://ec.europa.eu/tools/eudamed/#/screen/search-eo
EUDAMED SAP Add-On Update available
We released the EUDAMED SAP Add-On Version V2020/12. This Version contains many improvements like:Data handlingTranslations to ENPerformance optimizationsUDI Excel Template UpdateFor more details read the UDI Add-On EU Release Notes…
Swiss Medtech Day 2020 in Bern
Despite Corona, the Swiss Medtech Day 2020 was able to take place in Bern in compliance with safety arrangements. Europe IT Consulting GmbH was also part of the event and…
Excel template for managing your UDI data
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…
UDI Platform for SAP to manage data for FDA, EUDAMED and other authorities
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…
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…