UDI

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Providing UDI data to Hospitals & GPOs Part 3

Providing UDI data to Hospitals & GPOs Part 3

As a company, we didn’t do business with Group Purchasing Organizations (GPOs). Our strategy was to have a direct relationship with the customer. However, with UDI data, that changed.

Providing UDI data to Hospitals & GPOs Part 2

Providing UDI data to Hospitals & GPOs Part 2

Shortly after the FDA published the deadline for submitting UDI product information for Class II devices, I received an email from one of our sales representatives asking for help in submitting UDI data to one of our clients, a healthcare network consisting of several hospitals, medical centers, clinics, and a university health center.

Providing UDI data to Hospitals & GPOs Part 1

Providing UDI data to Hospitals & GPOs Part 1

As with most medical device companies, our journey into the world of UDI began with the introduction of new FDA requirements to publish product data with a unique number assigned to the product, such as a Global Trade Item Number (GTIN), in the FDA database.

The 12 Most Important Steps to Global UDI Compliance

The 12 Most Important Steps to Global UDI Compliance

The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023  The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people's health: Things like...

Device Registration ‘is live’ for voluntary UDI data submission

Last week, the European Commission announced the successful launch of its EUDAMED “Device Registration” and “NBs & Certificate” modules (Production release “v2.0 - September version” was deployed).  The EUDAMED UDI/Device Registration and NBs...

Global UDI Syndication Hub: Comparing Two Data Flow Models

First things first.  What exactly is a Data Flow Model? A data flow model is diagrammatic representation of the flow and exchange of data within a system. Data flow models are used to graphically represent the flow of data in an information system...

UDI Submission for China NMPA

Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market.  It is a potential high-growth area for many global medical device manufacturers.  So, if you’re a...

FDA Delays UDI Deadline for Class I Devices to September 2022

The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices.  Effective immediately, the FDA has postponed GUDID (Global UDI...

GUDID and UDI – Are You Prepared?

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify...

Is PTC Windchill Exiting the UDI Compliance Market?

Is PTC Windchill Exiting the UDI Compliance Market?

If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation.  Recent announcements...

The Latest UDI News: Convenience Kits Q&A from the FDA

Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for...

Complying with UDI & MDR: Facts, Figures and Action Items

Complying with UDI & MDR: Facts, Figures and Action Items

Manufacturers of medical devices and companies that supply them must provide products and services that are both safe and effective.  And today’s mounting list of regulations, medical device compliance is important to the success of every medical...

UDI Compliance: The Key Dates

UDI Compliance: The Key Dates

In 2013 the Food and Drug Administration issued a final rule setting out a system for Unique Device Identifiers, or UDIs, that should be applied to medical devices. These UDIs must be in both plain text and a format that can be read by a machine,...

Let’s Talk UDI (and a Webinar!)

Unique device identification (UDI) for medical devices is getting more visibility that ever.  And with upcoming compliance deadlines around the corner, more healthcare manufacturers are asking for clarity - “what is it?” and “how do I prepare?” ...

UDI: Generating Value Beyond Compliance

UDI: Generating Value Beyond Compliance

Getting to Good Data in the GUDID* The United States Food and Drug Administration (FDA) regulation mandates that UDI data for Class I medical devices to be submitted with an impending deadline of September 24, 2018.  This has made medical device...

The Adoption of UDI Globally; What does this mean for you?

The Adoption of UDI Globally; What does this mean for you?

UDI (Unique Device Identification) was legislated by the FDA on 24 September 2013.  Device manufacturers were warned that failure to comply with UDI submission requirements would prevent them from selling products in the United States. It’s been...