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FDA: Software Assurance guidance for Production and Quality System Software

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This draft guidance is intended to: Computer Software Assurance is a risk-based approach to establish confidence in the automation used for production or quality systems, that software is fit …
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Language requirements for Manufacturers – Europe

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Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to establish national language requirements for makers of device companion materials. …
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Mexico: Modifications to Medical Device Registration

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In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated the Guidance Document by defining types and impact of product or organizational ch…
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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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