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K2M Case Study: Tackling UDI and What Comes Next


K2M Case Study: Tackling UDI and What Comes Next

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Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, […]

Webinar: From UDI to GDSN: How The Medical Device Data Landscape Keeps Evolving

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Join John Lorenc from Reed Tech, Becky Aldhizer from STERIS Corporation, and Scott Brown from 1WorldSync as they discuss commercial data exchange efforts through GDSN. WATCH NOW FOR: The basic principles of GDSN and how it works How STERIS Corporation pivoted from UDI compliance to commercial data exchange efforts Best practices for collecting, storing, managing […]

Don’t Forget—Medical Device Data Submission Deadlines in 2018

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Beginning in September of 2014, medical device manufacturers have faced a series of data submission and maintenance requirements from the FDA as part of its Unique Device Identification (UDI) initiative. The agency phased the compliance deadlines by device class, requiring the highest risk device records to be submitted first to its Global Unique Device Identifier […]

Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels

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Horsham, Penn. – July 9, 2018 – Reed Technology and Information Services Inc. (Reed Tech), a provider of high-quality data management and analytics solutions for the life sciences industry, announces the launch of Reed Tech Navigator™ for Drug Labels. Navigator for Drug Labels is a research solution designed to enable in-depth search, monitoring and analysis of drug […]

FDA Drug Listing: When You Need a Manual Override

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One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents are automatically checked against the SPL schema and FDA business rules. If a file […]

Webinar: FDA Drug Listing Requirements for Manufacturers & Distributors

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Join Jon Nolan and Gary Saner of Reed Tech to learn about FDA requirements for electronic Drug Listing and their application to Contract Manufacturing (CMO) and Private Label Distributor (PLD) organizations. WATCH NOW FOR: Electronic Drug Listing Environment History and Future Trends Requirements Overview for Contract Manufacturers and Private Label Distributors Recent FDA Changes to […]