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FDA: Software Assurance guidance for Production and Quality System Software

This draft guidance is intended to: Computer Software Assurance is a risk-based approach to establish confidence…
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Language requirements for Manufacturers – Europe

Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to est…
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Mexico: Modifications to Medical Device Registration

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated th…
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Is Regulatory Team Overworking but Unproductive?

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 t…
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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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