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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 […]

Webinar: EU MDR’s Impact on Labeling: UDI in Europe and Other Changes

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Gary Saner of Reed Tech and Mark Cusworth of PRISYM ID discuss the new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and the impact on labeling, including label formats, IFU information and symbols. WATCH NOW FOR: Label requirements comparison EU MDR vs MDD and AIMDD Comparison of EU MDR & FDA UDI […]

The Continuing Evolution of UDI: Highlights from the 2018 UDI Conference (Part 2 of 2)

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Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here. FDA Makes GUDID Changes to Improve Data Quality Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality campaign during multiple sessions. In particular, Indira Konduri of […]

UDI Flows Downstream: Highlights from the 2018 UDI Conference (Part 1 of 2)

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 At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one overarching theme to the conference presentations and conversations overheard in the exhibit hall, at the lunch […]