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EUDAMED Requirements of Legacy Device Registration in UDI Module

MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique D…

EUDAMED Vigilance Requirements and Steps

One of the modules of EUDAMED is Vigilance and Market Surveillance. EUDAMED will become mandatory for device Actors,…

How Device Companies Can Drive Regulatory Digitization

The last few years have brought unprecedented challenges, opportunities, and evolution for companies of all sizes. T…

Benefits of IRT in Decentralized and Hybrid Clinical Trials

In recent years, decentralized and hybrid clinical trials have emerged as promising alternatives to traditional clin…

Singapore UDI Phase – 1 Implementation

The Health Sciences Authority of Singapore will implement the UDI system, a global system for tracking and identifyi…

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