Successful ISO 9001:2015 Recertification
Europe IT Consulting Successfully Recertified to ISO 9001:2015 On August 6, 2025, Europe IT Consulting GmbH underwent its surveillance audit conducted by QS Zürich AG. The audit report confirms full…
All posts by Ugur Müldür
Update: EUDAMED Rollout Timeline Under Review (July 2025)
The European Commission has released an updated EUDAMED rollout plan (July 2025) – this time with a clear note: the timeline is now “under review”. This indicates that, as part…
Timelines for the Introduction of the Master UDI-DI
MDCG Publishes Timelines for the Introduction of the Master UDI-DI for Eyewear and Contact Lenses The Medical Device Coordination Group (MDCG) has released its MDCG 2025-7 position paper, setting out…
Medical device sales market in Türkiye: opportunities and challenges
Executive Summary Turkey is developing into an important sales market for medical devices with a population of 85 million inhabitants and a growing healthcare economy. Despite economic challenges, the medical…
FDA Electronic Medical Device Reporting
What is eMDR? eMDR (Electronic Medical Device Reporting) is the US FDA's electronic reporting system for vigilance cases related to medical devices. This system enables the structured and standardized reporting…
Key Dates: UDI Requirements in Australia
New Schedules for Unique Device Identification (UDI) in Australia The Australian Therapeutic Goods Administration (TGA) has announced the binding timetables for the implementation of the UDI requirements. The UDI system…
Master UDI: The next level of medical device identification
The introduction of the Medical Device Regulation brought about a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices.This step has been taken to improve the identification,…
EUDAMED Update: Version 3.11.0 Playground
On April 24, 2025, the European Commission released a new technical update for the EUDAMED test environment (Playground). Version v3.11.0 includes significant enhancements, particularly in the UDI/Devices module. Key Updates…
Swissdamed UDI mandate begins July 2026
The Swissdamed platform continues to take shape – and with it the regulatory obligations for manufacturers and distributors of medical devices in Switzerland and Liechtenstein. A central module is now…
Overwhelming Response to Our EUDAMED Webinar!
We are thrilled by the enormous interest in our free expert webinar on the EUDAMED database! With over 700 registrations, we clearly felt how relevant and important this topic is…