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FDA Insight: UDI Data Quality
Despite Extension, 2017 UDI Deadline Still Holds for Certain Contact Lenses
FDA delayed the UDI deadline for soft contact lenses to a future undetermined date but the September 24, 2017 deadline for rigid, gas-permeable contact lenses remains unchanged.
Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™
The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data through the GDSN.
UDI Update: New FDA GUDID Technical Documents Released
FDA sent an email to its list of UDI GUDID email subscribers with updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation Files.
UDI & GDSN Webinar - Making the most of your GUDID Data
GDSN expert Peter Alvarez of GS1 and UDI expert Gary Saner of Reed Tech discuss how medical device labelers can utilize the Global Data Synchronization Network (GDSN) to capitalize on their investment
Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync
This agreement will allow Reed Tech customers to access the Global Data Synchronization Network (GDSN) and provide 1WorldSync customers with expanded options for managing their regulatory data.
GS1, GTIN, GDSN--What do they have to do with UDI?
If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, like “GS1,” “GTIN” and “GDSN.”
UDI Post-GUDID Publishing Webinar
UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.
UDI Data Security: Why it should be important to you
Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio.
Data Submitted! But the UDI Journey Continues...
September 24 and the Class II UDI deadline compliance date is past. But UDI is not over. For medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.
UDI Data Submission Case Study: Henry Schein
As the Henry Schein team was faced with collecting...and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming.
Time is Up! Class II UDI Deadline Tomorrow
For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.
UDI Q&A with Jay Crowley and Gary Saner
On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.
FDA UDI Class II Extension: Does it apply to your products?
This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices.
UDI: Best Practices in Data Management, Barcoding and Direct Marking
UDI experts Gary Saner (Reed Tech) and Michael Barron (Domino) discuss best practices for medical device labelers seeking to comply with the FDA's Unique Device Identification mandate.
Just 25 Business Days Remaining Before the Class II UDI Deadline!
If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?
What's the real cost of UDI compliance?
UDI team leaders should ask themselves these important questions about the total costs of their UDI data submission and management plan.
FDA UDI Enforcement
How will the FDA enforce the requirements of the UDI Final Rule? This video details what the FDA has said so far and what we can expect for UDI policing based on prior agency enforcement tactics.
Should you DIY UDI?
DIY is a growing movement. But for DIY projects, you should always use the right tool for the job and take advice from an expert. Is DIY for UDI the right approach for your organization?
UDI Post-Submission Responsibilities