Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation

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Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
LexisNexis Reed Tech and 1WorldSync collaborate to provide medical device manufacturers with a comprehensive solution for managing regulatory UDI submissions and syndicating accurate product data globally.
Learn four strategies to simplify UDI and GSDN data management for medical device companies and ensure compliance
With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED.
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations.
During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market...
On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
Quick Insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers.