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Is Regulatory Team Overworking but Unproductive?

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We’re taught from an early age that hard work is key for success. What we’re not taught is that hard work comes in two equally important forms: effort to perform and effort to improve. Team’s l…
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Swissmedic Device/IVD Database Key Dates

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Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MR…
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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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