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Recent Blogs
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication. The collaboration pairs Reed Tech SingleSource™ for Medical Devices, which provides UDI regulatory data management technology, with 1WorldSync’s Global Data Synchronization Network (GDSN) capabilities. This allows MedTech companies to centrally manage and share product data required by global health authorities, customers, and stakeholders. The alliance assists the medical device industry in providing product information to regulatory systems, retailers, healthcare providers, and consumers, offering a comprehensive product data solution.
UDI Implementation Tips and GDSN Data Management
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management Tracking medical devices...
How US Agent Services from Reed Tech help Global MedTech Companies
Did you know? Reed Tech helps global companies comply with FDA regulations and efficiently enter the US market through dedicated US Agent Services. We serve as the FDA point of contact for non-US based drug, biologic, and device establishments on behalf of companies based outside the US.
Discontinuation and Relisting Features added to MoCRA
The U.S. Food and Drug Administration (FDA) has recently announced the release of two new features for cosmetic product registration and listing. These new Modernization of Cosmetics Reform Act of 2022 (MoCRA) features are designed to simplify the process of managing cosmetic product information for responsible persons.
FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format
The FDA has issued the final guidance “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This new guidance mandates electronic submission of all Over-the-Counter (OTC) monograph materials, marking a significant shift in the regulatory landscape. By transitioning to electronic submissions, the FDA has expressed aim to streamline the review process, enhance transparency and facilitate faster decision-making for OTC drug approvals.
Takeaways from DIA Global Annual Meeting in San Diego
This past June, Reed Tech Life Sciences team members attended the 60th Anniversary of the DIA Global Annual Meeting in San Diego, California.