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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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Automation: What Regulatory Team Needs to Know Before Investing

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In recent years, Automaton has become more powerful and its applications to business have increased dramatically. As a result, companies and business functions, including Regulatory, that hadn’t s…
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What EU MDR changes mean to Manufacturers & what’s Next !

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With EU MDR timelines extended, some brief analysis for manufacturers: Devices benefitting The extension provisions apply to a device if: It was certified by a notified body under the Me…
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