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EUDAMED Requirements of Legacy Device Registration in UDI Module

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MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique Device Identifier (UDI) and oblige medical device manufacturers to disclose the U…
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EUDAMED Vigilance Requirements and Steps

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One of the modules of EUDAMED is Vigilance and Market Surveillance. EUDAMED will become mandatory for device Actors, Vigilance, Clinical Investigation/Performance Studies and Market Surveillance M…
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How Device Companies Can Drive Regulatory Digitization

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The last few years have brought unprecedented challenges, opportunities, and evolution for companies of all sizes. The small and middle market is no exception. In fact, the pandemic served as an a…
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Benefits of IRT in Decentralized and Hybrid Clinical Trials

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In recent years, decentralized and hybrid clinical trials have emerged as promising alternatives to traditional clinical trials. Decentralized clinical trials (DCTs) refer to studies in which part…
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Singapore UDI Phase – 1 Implementation

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The Health Sciences Authority of Singapore will implement the UDI system, a global system for tracking and identifying medical devices. The core components of Singapore’s UDI system are in accorda…
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