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Medical Device Product Data Management

Medical Device Product Data Management

UDI: A Guide to Device Identifiers

UK NHS eProcurement: The What, Who, Why and When

Reed Tech SingleSource™ for Medical Devices

K2M Case Study: Tackling UDI and What Comes Next

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...

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

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,...

Webinar: Harmonizing your EU MDR Efforts with FDA UDI

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...

FDA is Sharpening its Focus on UDI Data Quality

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...

Webinar: NHS eProcurement Requirements in 2018

Gary Saner of Reed Tech discusses of what medical device companies need to do in 2018 to comply with the National Health Service eProcurement requirements and how affected medical device labelers can meet the deadline. WATCH NOW TO LEARN: UK NHS eProcurement...

Webinar: UDI and the EU MDR: What You Need to Know

In this webinar, you’ll get an overview of the requirements for the upcoming Unique Device Identification (UDI) initiative in the EU from Reed Tech and PRISYM ID team members. Presenters Chris Lentz, Gary Saner and Phil Dray will address the following: EU MDR /...

NHS eProcurement Q&A

Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to...

UK NHS eProcurement: The What, Who, Why and When

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

FDA Insight: UDI Data Quality

On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day...

UDI Update: New FDA GUDID Technical Documents Released

Did you know that FDA recently updated some technical documents related to GUDID submissions? On March 31, the agency sent an email to its list of GUDID email subscribers with links to an updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation...