Swiss UDI Requirement – Everything you need to know
SWISSDAMED - The swiss UDI database The Mutual Recognition Agreement (MRA), one of the main agreements between the EU and Switzerland facilitating bilateral trade in a number of key sectors…
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Streamlining Compliance: OPAL & Europe IT Consulting
Streamlining Compliance: OPAL Labelmanagement & Europe IT Consulting => Perfect Pair for UDI and Labeling As medical device manufacturers prepare to comply with the EU Medical Device Regulation (MDR), one…
UDI TGA Australia postpones the compliance date which was planned for June 2023
News Update: Unique Device Identification (UDI) Compliance Date Deferred We have some important news to share with you about the Unique Device Identification (UDI) compliance timeframes. As you may recall,…
EUDAMED Master UDI-DI
Did you heard about "EUDAMED Master UDI-DI" ? Here are the latest news about it and why the Master UDI-DI is needed. The European Commission is amending Regulation (EU) 2017/745…
Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers
Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers In the medical device industry, compliance with regulatory requirements is crucial for ensuring patient safety and product quality. One…
We are on SAP ARIBA
We are excited to announce that our company is now available on SAP Ariba! This platform is a leading provider of procurement and supply chain solutions, connecting buyers and sellers…
Happy Christmas
Merry Christmas and Happy Holidays to all of our valued customers! We hope this holiday season brings you joy, love, and plenty of time to spend with your loved ones.…
We have managed to become ISO 9001 certified
We are now ISO 9001:2015 certified - Celebrate with us! After weeks of preparation, we successfully passed the ISO 9001 audit on 11.08.2022. During the preparation time and the implementation…
EUDAMED: How to update market information?
Perhaps you have already asked yourself which information should be entered in the EUDAMED database in the "Market Information" area. According to our request to the European Commission, the following…
Visit to the “MedtechLIVE with T4M”
We visited MedtechLIVE 2022 in Stuttgart, were able to look at interesting new developments and meet customers and partners. The issue of EUDAMED and MDR seems to have moved into…