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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 […]

Webinar: Harmonizing your EU MDR Efforts with FDA UDI

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Gary Saner and John Lorenc of Reed Tech discuss UDI requirements in the EU and how device companies can align their EU compliance efforts with existing FDA UDI programs. WATCH NOW FOR: EU MDR / IVDR Overview EU UDI Requirements and Comparison to FDA UDI Global Data Management Approach Q&A Please complete the form to […]

FDA is Sharpening its Focus on UDI Data Quality

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In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira Konduri reminded medical device industry members to avoid common data quality errors […]