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Swissmedic Device/IVD Database Key Dates

Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices d…
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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…
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EUDAMED Vigilance Requirements and Steps

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

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