WEBINAR

Why a regulatory information strategy is critical for successful MDR/IVDR transitions

Replay

The significant changes introduced with the MDR and IVDR regulations have created both a need and an opportunity for RA teams to leverage a better approach to regulatory information management. This webinar explores the new information requirements associated with MDR/IVDR including GSPRs, UDI/EUDAMED, and Post-market surveillance and reporting, and and how a shift to a product-centric vs project-centric approach can make information more accessible and usable across teams and processes.

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Why a regulatory information strategy is critical for successful MDR/IVDR transitions

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Check out these additional resources
5 ways a RIM system can accelerate time-to-market for MedTech companies
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A primer on medical device classification
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Quick reference guide - global medical device UDI requirements and timelines
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