The EC plans to postpone the EU MDR 2017/745 by one year
The European Commission is planning a possible postponement of the EU MDR 2017/745 by one year. After the postponement of the technical GoLive of EUDAMED by two years to May…
The European Commission is planning a possible postponement of the EU MDR 2017/745 by one year. After the postponement of the technical GoLive of EUDAMED by two years to May…
Importants UDI links of the FDA/GUDID The FDA has laid the foundation with its UDI system and the GUDID database. Many countries have not yet reached the stage to enable…
Important UDI links to EUDAMED Since the introduction of MDR 2017/745 and IVDR 2017/746 of the European Commission (EC), medical device manufacturers have been facing new challenges and major changes.…
EUDAMED Database Structure Keywords: MDR, IVDR, EUDAMED, Modules, ACT, UDI, CRF, CIPS, VGL, MSU What is EUDAMED? The EUDAMED stands for "European Database for Medical Devices" and is operated by…
UDI system of the FDA To comply with the legal requirements of the FDA, medical device manufacturers must comply with the UDI (Unique Device Identification) requirements in the future. All…
With the adoption of the new EU Medical Device Regulation (MDR) by the European Parliament on April 5, 2017, the European UDI Regulation on the Labelling and Registration of Medical…
The FDA has laid the foundation with its UDI system and the GUDID database. Many countries are not yet ready to allow medical device manufacturers to automatically upload their data.…
Europe IT Consulting GmbH supports a medical technology manufacturer in the implementation of UDI in SAP. Through a gap analysis, the customer was able to define a project plan adapted…
The Swiss Medtech Expo is the trade fair for the third largest medtech market in Europe. At this leading platform, system and component suppliers, specialized service providers as well as research…
Winterthur: Europe IT Consulting GmbH supports a medical technology manufacturer in the implementation of UDI in SAP. Through a fit gap analysis the necessary activities could be defined and the…